DESC:TITLE
SNAP NEEDLE AUTOINJECTOR CARTRIDGE SYSTEM
FIELD OF THE INVENTION
[001] The present invention relates to drug delivery devices. Particularly a standard cartridge that accommodates the classic injection system that relates to needle and hub assemblies which drives the automatic injection devices. More particularly, the invention discloses an auto injector that consists of a floating needle that 'snaps' (snap needle) onto a cartridge based container closure system enclosed in a protective needle cover (NCV) that automatically locks into the body of the injector. The injection system comprising of an improved glass cartridge (CA), which connects to a snap needle hub (SN) onto the distal end and grips various two bevel angle needle (NL) of sizes 27G to 30G with a protective needle cap (NCP) and comprises the plunger assembly (PL), body (BO), with compression spring and button (BU) at the proximal end of the device provisioned for the mechanism of drug delivery.
BACKGROUND OF THE INVENTION
[002] At present, to perform an injection across a wide array of therapeutic sectors apart from the traditional domains, the auto injectors are extensively employed owing to the ease of self-administration, dosing accuracy, safety, convenience, distress and reduced risk of contamination. However, these syringes are excessively complex, expensive, inadequate and unapproachable to majority of the consumers in healthcare industry. Furthermore the auto-injectors generally available in many different configurations may hamper the static needle to deliver biologics. To aid convenience in injecting drugs it is desirable to simplify the process by inserting the needle at ease into the delivery site, delivering the drug and subsequently sheathing the needle with minimal user input. There is a continuing need for improved auto-injector apparatus that are simple and reliable in their use and economical in their manufacture.
[003] In general, disposable auto-injectors are the most-preferred auto injectors due to their ease of use and the presence of a built-in glass syringe that eliminates the need of manual loading the glass syringe, which makes it more convenient for patients with reduced dexterity or visual impairments. The specifically designed cartridges addresses certain issues and challenges in healthcare industry by the use of widely available injectable device components to construct the design device suitable for auto-injector system is laborious, time consuming and cost effective.
[004] Auto-injectors are relatively complex devices and the robustness of the device is, in its handling and ease of use. There are numerous auto injectors in the market, but are with certain number of drawbacks. The major drawbacks of an auto-injectors are while holding the device and disposing the medicament, and in general the auto-injectors are deceptively failed or accidentally triggered due to prevailing delivery devices systems To aid convenience in injecting drugs with safety mechanism, it is desirable to simplify the process by implanting the reliable trigger lock and constricted needle hub assembly into the delivery site, delivering the drug and subsequently sheathing the needle with minimal user input. At present, there is a need for improved auto-injector apparatus that are simple, safe and reliable in their use and economical in their manufacture, since most auto injectors are for single use, the cost of manufacture and of assembly considered to be the major provisions.
[005] In order to satisfy the constraints and requirements, the present invention established a customized technically designed reliable innovative auto-injector device that is easy and intuitive in allowing the people to use with no or minimal medical training by providing a safe, reliable, simple, inexpensive with minimal risk of injury is established by smearing new technology in designing and manufacturing of the anticipated device. The main object of the present invention is to provide an auto-injector by designing a reliable trigger lock, the ease with which an auto injector can be actuated by decreasing the risk of needle-stick injuries, accidental exposure, device failure and dose quality accuracy, by increasing the efficacy and reducing the risk of needle-related phobia disorder.
[006] The major concern with the practice of auto injectors are due to incorrect orientation of the device. The errors are clearly consigned to the individual design and interface elements and classified as user errors and operational difficulties, mostly the needle stick injuries due to accidental firing, stacked needle, poor usability, insufficient in identification of the needle and needle cap, distinguishing between the dose setting and actuation button, and corresponding negative safety outcomes in the usage flaws. A critical step in the process is the identification of errors affecting the existing prior art devices, in order to avoid the stated glitches during the device operation, a novel design with advanced components with the minimal cost of manufacture is essential that systematically analyses the user errors associated with auto injectors
[007] As the global auto injector market is exposed to grow further in coming years, and the technology is evolving rapidly, the present invention is progressed and developed an upgraded innovative device, by considering the latest tendencies and developments in terms of both usability and safety for the benefit of users.
SUMMARY OF THE INVENTION:
[008] The present invention is a novel autoinjetor, a sterile medical device for the safe, convenient and mechanical administration of the precise parenteral medications claimed to reduces the risk of accidental injection and user friendly. An auto injector that consists of a floating needle that 'snaps' (snap needle) onto a cartridge based container closure system enclosed in a protective needle cover that automatically locks into the body of the injector. This construction enables the simplified and economical construction of the auto injector with reduced number of injection moulded parts and yet critically maintains the integrity of the drug container closure. The floating snap needle is only activated at the time of parenteral drug administration. Furthermore the needle uses a fine 30 G needle that eases the pain for the patient for subcutaneous drug administration.
[009] Present invention delivers an auto injector with a standard cartridge and needle hub assembly, for administration of medicament. There are five major components of the present device which includes a standard glass cartridge (CA), a snap needle hub (SN), a needle cover (NCV), a plunger assembly (PA) and a Body (BO) accompanying the Needle Cap (NCP), Button (BU) and compression spring situated between the proximal and distal ends that supports the mechanism of drug delivery.
[010] In an aspect of the present invention, an auto-injector is an intricate device encompasses: (a) a standard glass Cartridge (CA) used to contain a particular amount of medicine dose and (b) the Rubber Plunger (RP) situated inside of the standard cartridge to maintain drug integrity and to push the injection dose from cartridge, (c) a Snap Needle Hub (SN) is provided to hold needle & cartridge where one end of snap needle hub is hollow cylindrical to accommodate needle in it and the other is provided to accommodate cartridge head at the operational end (d) a Needle Cover (NCV) to cover the needle and holds the snap needle and guide the cartridge and prevents the accidental opening of needle cap (e) a Plunger (PL) acts as a capsule and provides the base for compression spring used to push the rubber plunger for medicine dose injection and disengage NCV actuation prongs from BO rectangular groove (f) a Body (BO) used to hold & guide the components namely needle cover, plunger & button (g) Needle Cap (NCP) support the prongs to prevent downward movement of cartridge before use and prevents contact of needle with external element (h) Button (BU) is used to initiate the operation of dose injection and guides the compression spring (i) Compression Spring is provided to get the forward movement of plunger and delivers force for snap needle hub engagement with the cartridge (j) Retractor Spring (RTSP) one end rests at the bottom of snap needle hub & another end is connected to the surface of needle cover and used to prevent forward movement of snap needle hub easily and move the needle cover in forward direction at the operational end to cover needle (h) Needle (NL) is 30 Gauge, two bevel angle on both the side used to penetrate cartridge before medicine dose injection and puncture the human body and inject medicine dose.
[011] However mechanizing the auto-injector device is a highly complicated practice as it requires the accumulation of different components to assemble and construct an expedient device that the user does not see the needle even after the injection operation and the protective cover prevents the accidental or unwanted contact with the projecting needle and it requires the automatic injector to effectuate relative movement of needle cover with respect to the body. The complexity is added where the protective needle cover is initially retracted with respect to the injector body and plunger and has the capability of being locked in the extended position wherein it covers the projecting needle and reduces the risk of injury during the accidental firing or triggering and the snap needle hub holds the needle and cartridge in a position and restricts the downward movement of cartridge initially and prevent penetration of needle in cartridge and blocks the accidental injuries during administration.
[012] The mechanism of the auto-injector is to deliver the medicament in the uniform dissemination owing to the assemblage of the devise components to drive the actuator in a fashioned innovative manner where the unique features of the present auto-injector designed in usage of 1.8ml glass cartridge instead of prefilled syringes as most of the existing prior art and the advantage is that the needle is not in contact with the vial and have an elastomeric septum seal at one end rather than a needle and do not have the flange seen on syringes and aids in ease of drug administration. The needle cover tabs prevents the accidental opening of the needle cap and used to hold and guide the cartridge and the dose is always visible in the cartridge and the primary function of the needle cover is to hold the snap needle in needle cover rectangular slots at initial position and to cover the needle after medicine injection in human body. The snap needle hub is a unique feature over the existing prior art as the cartridge support tabs of the snap needle restricts the downward movement of cartridge initially and prevent penetration of needle in cartridge, and snap needle slots allow the needle cap rotation to remove it from the device and so designed that it accommodate needle in it and the cartridge takes place at the middle of snap needle core void at the end of medicine dose injection. The stated unique features of the auto-injector device is an innovative finding that have number of advantages over the existing prior art devices including reducing the risk of needle-related phobia disorder, decreasing the risk of needle-stick injuries, accidental exposure, triggering or firing, device failure, maintaining dose quality accuracy, and increasing efficacy.
[013] Present invention is a laborious and cost effective by utilizing less number of components for designing the device in a safe and user friendly manner and many manufacturing companies seeking improved injection devices that provide comprehensive advantage over the prior art, however the present invention solves the existing problem by domicile manufacturing and supplying of the widespread comprehensive auto-injector cartridge assembly by accruing the intact components by simplifying and standardizing the traditional production process. Nevertheless, this type of auto-injector has now sparked a significant amount of commercial interest.
DETAILED DESCRIPTION OF THE INVENTION:
[014] The present invention thus provides an autoinjector comprising,
A. CARTRIDGE (CA): containing particular amount of fluid medicament dose extent of 1.8ml.
B. RUBBER PLUNGER (RP): is used to maintain drug integrity and to push the injection dose from cartridge. Open end of the rubber plunger surface comes in contact with the plunger and other end surface comes in contact with the dose directly.
C. NEEDLE COVER (NCV): Main features: NCV Grip bumps, NCV Rectangular slots, NCV Retainer tabs, NCV Inside holders, NCV Actuation prongs, NCV Protective tabs It has eight bumps at outside surface for the proper grip and alignment of itself inside the body and which are called as NCV grip bumps (as shown in Figure 4). It has two NCV rectangular slots (as shown in Figure 5) to hold the snap needle at initial stage. It has two NCV Retainer tabs (as shown in Figure 4) for the initial locking of the needle cover with body. It has eight holders inside to align & hold the cartridge properly so it is called as NCV inside holders (as shown in Figure 4). It has two small NCV Protective tabs (as shown in Figure 4) at the most bottom of needle. It has two NCV Actuation prongs (as shown in Figure 6) at the top of needle cover to release the NCV Retainer tabs at end of medicine injection.
D. PLUNGER (PL): Main features: PL working prongs, PL Actuation helper prongs
It has total six prongs at the top; two middle prongs are bigger than others and called as PL Working prongs. Initially two middle prongs are rests in the L slots of body. Forward push movement of the button by user disengage the two middle prongs from the L slots of body. So that, plunger get forward movement due to expansion of compression spring. Another four prongs are provided to get required force to unlock the Needle cover prongs from the grooves of body and called as PL Actuation helper prongs. At the end the plunger’s two PL Working prongs will take the position in the grooves of the body. Function: It acts as a capsule and provides the base for compression spring. It is used to push the rubber plunger for medicine dose injection in human body. PL working prongs & PL guide prongs are used to disengage NCV actuation prongs from BO B rectangular groove.
E. SNAP NEEDLE HUB (SN): Main features: SN Cartridge support tabs, SN Spring support tabs, and SN Core void, SN prongs. Snap needle hub is provided to hold needle & cartridge. One end of snap needle hub is hollow cylindrical to accommodate needle in it. It also supports one end of retractor spring; one end of the retractor spring rests at the bottom of SN core void to prevent downward movement of snap needle hub easily. It has diametrically opposite two tabs connected with SN prongs called SN Cartridge support tab, which is used to support cartridge at initial operational stage. It has two SN Spring support tabs which are used to prevent sliding of retractor spring. It has two SN slots at the middle portion diametrically opposite to each other to accommodate the rotational movement of needle cap. The SN core void of the snap needle hub is provided to accommodate cartridge head at the operational end. Function: SN Cartridge support tabs restricts the downward movement of cartridge initially and prevent penetration of needle in cartridge. SN slots allow the needle cap rotation to remove it from the device.
It is so designed that it accommodate needle in it. It is so designed that at the end of medicine dose injection the cartridge takes place at the middle of SN core void.
F. RETRACTOR SPRING (RTSP): One end of the retractor spring rests at the bottom of snap needle hub & another end is connected to the surface of needle cover. Function: It is used to prevent forward movement of snap needle hub easily. Another function of retractor spring is to move the needle cover in forward direction at the operational end to cover needle.
G. BODY (BO): Main features: BO L slots, BO Tactile bump, BO A & B Rectangular grooves, BO Dose visibility slots, BO holding ribs. It is used to hold the components namely needle cover, plunger & button. It has two BO L slots near top to provide holding space for plunger prongs & button. It also serves the space for forward movement of button to unlock the PL working prongs from BO L slots. It has two bumps besides BO L slots to prevent self-rotation of button & it also provide tactile feeling to the user and it is called as BO tactile bump. It has two sets of rectangular grooves at middle one below another from top, one is used to hold needle cover at initial position & another at the final position so it is called as BO A rectangular grooves & BO B rectangular grooves respectively. It has two big straight slots near its end diametrically opposite to each other for the visibility of dose in cartridge so it is called as BO dose visibility slots. It has four BO holding ribs inside, to hold, align & guide the movement of plunger. Function: It is used to hold & guide the components namely needle cover, plunger & button. BO dose visibility slots allow the visibility of medicine dose. Patient will be holding the body while use.
H. NEEDLE CAP (NCP): Main features: NCP Support prongs, Needle cap is provided to prevent contact of needle with external element before use. It is so designed that it cannot open accidentally. Needle cap also provide support to the cartridge before opening by diametrically opposites two NCP Support prongs at top. The bottom outside surface of the snap needle cap has serrations for the proper grip. It has through two through holes at the middle diametrically opposites to each other. Function: NCP Support prongs prevent downward movement of cartridge before use. The serrations at the bottom provides proper grip to the user. It prevents contact of needle with external element. Through holes at the middle are used for the engagement of needle cover protective tabs.
I. NEEDLE: Main features: is a floating needle that snaps and accommodates variable needle sizes such as 27 Gauge to 30 Gauge, provided with bevel angle on both the side of needle. Function: It will penetrate cartridge before medicine dose injection in human body. Needle is used to puncture the human body and inject medicine dose.
J. BUTTON (BU): Main features: BU Actuation tabs, BU tactile dips, BU Taper guide
It has two BU actuating tabs and four BU tactile dips diametrically opposite to each other inside the button. Two BU actuating tabs are provided to disengage the PL working prongs of plunger from BO L groves of body. Four BU tactile dips are provided to achieve engagement in the opposite tactile bumps of body & to prevent self-rotation of button. Clockwise rotation and forward push movement of button by user cause the disengagement of plunger’s PL working prongs from the BO L slots of body. So that, Plunger moves forward due to expansion of spring. Middle BU tapper guide portion of button is provided to rest & guide the compression spring. Outer surface of the button has serrations to achieve proper grip. Function: Button is used to initiate the operation of dose injection. The outer serrations provides proper grip to the user. The BU Taper guide guides the compression spring. BU Actuation tabs used to disengage the PL working prongs.
K. COMPRESSION SPRING: Function: Compression spring is provided to get the forward movement of plunger. It also provides force for snap needle hub engagement with the cartridge.
[012] DETAILED DESCRIPTION OF THE DRAWINGS
FUNCTIONING MECHANISM:
Step 1: Needle cap removal: Rotate the needle cap anti-clock wise and remove it for the dose injection
Step 2: Rotation the button anti-clock wise & placement of device on intended place of human body skin before dose injection. Rotate the button anti-clock wise before medicine dose injection
Step 2.1: Place the device on human body skin. Place the device on human body skin where the penetration intended before pushing the button.
Step 3: Push the button forward for medicine dose actuation, Push the button in forward direction it cause the contraction of PL working prongs of plunger due to the pressure of BU Actuation tab.
Step 3.1: Penetration of needle in cartridge, The BU Actuation tab moves forward and push the PL working prongs of plunger inside. PL Working prongs of plunger contracts and moves forward due to expansion of injection spring. Simultaneously cartridge and rubber plunger moves in forward direction due to plunger pressure on and needle penetrate the cartridge. The dose in the cartridge does not move forward throughout these forward movements due to less pressure.
Step 3.2: penetration of needle in human body: Furthermore, as the plunger moves in forward direction due to expansion of injection spring, the rubber plunger, cartridge & snap needle also moves forward. The dose in the cartridge does not move forward throughout these forward movements of components namely, plunger, rubber plunger & cartridge due to less pressure. As shown in above figure 34 retractor spring compressed due to less stiffness and retainer spring retain the shape of snap needle hub by covering the outer periphery of it.
Step 3.3: Dose injection in human body: Now needle has been penetrated and the upper surface of snap needle has the contact with human body. The further forward movement of snap needle hub is not possible due to human body constrain. The further forward movement of plunger cause the dose injection in human body. The bellow figure 35 shows the position of plunger, cartridge, rubber plunger & snap needle hub at the end of dose injection.
Step 3.4: Needle covered by the needle cover after dose injection: When the device is removed from the human body after dose injection, the needle is covered by the needle cover due to the expansion of retractor spring as shown in bellow figure. The retainer spring prevent the re-engagement of snap needle prongs and rectangular slots of needle cover. The PL Working prongs of plunger takes the placement of NCV Retainer tabs in BO ‘A’ rectangular groove of body and the NCV Retainer tabs of needle cover takes the placement at BO ‘B’ grooves of body as shown in above figure. The above figure also depicts the final position of all the components after dose injection.
,CLAIMS:CLAIMS

We Claim:

1. A snap needle autoinjector cartridge system consists of a floating needle that snaps onto a cartridge comprising of,
a. A standard glass cartridge (CA)
b. A snap needle Hub (SN)
c. A protective needle cover (NCV)
d. A Plunger Assembly (PA)
e. Body (BO)
f. Needle Cap (NCP)
g. Button (BU)
h. Compression String (CS)
situated between the proximal and distal ends of the injection system that supports the mechanism of drug delivery.
2. A snap needle autoinjector cartridge system consists of a floating needle as claimed in claim 1, wherein the injection system comprising of an improved glass cartridge (CA), which connects to a snap needle hub (SN) onto the distal end and grips various two bevel angle needle (NL) with a protective needle cap (NCP) and comprises the plunger assembly (PL), body (BO), with compression spring and button (BU) at the proximal end of the device provisioned for the mechanism of drug delivery.
3. A snap needle autoinjector cartridge system consists of a floating needle as claimed in claim 1, wherein the floating needle snaps onto a cartridge based container closure system enclosed in a protective needle cover that automatically locks into the body of the injector.
4. A snap needle autoinjector cartridge system consists of a floating needle as claimed in claim 1, wherein the floating snap needle is only activated at the time of parenteral drug administration.
5. A snap needle autoinjector cartridge system consists of a floating needle as claimed in claim 1, wherein the snap needle is a fine 30 G needle that eases the pain for the patient for subcutaneous drug administration.
6. A snap needle autoinjector cartridge system consists of a floating needle as claimed in claim 1, wherein a standard cartridge that accommodates the classic injection system that relates particularly to floating snap needle and hub assemblies which drives the automatic injection devices.
7. A snap needle autoinjector cartridge system consists of a floating needle as claimed in claim 1, wherein a Snap Needle Hub (SN) is provided to hold needle & cartridge where one end of snap needle hub is hollow cylindrical to accommodate needle in it and the other is provided to accommodate cartridge head with medicament at the operational end.
8. A snap needle autoinjector cartridge system consists of a floating needle as claimed in claim 1, wherein Needle Cap (NCP) support the prongs to prevent downward movement of cartridge before use and prevents contact of needle with external element.
9. A snap needle autoinjector cartridge system consists of a floating needle as claimed in claim 1, wherein the protective needle cover (NCV) is initially retracted with respect to the injector body and plunger and has the capability of being locked in the extended position wherein it covers the projecting needle and reduces the risk of injury during the accidental firing or triggering.
10. A snap needle autoinjector cartridge system consists of a floating needle as claimed in claim 1, wherein snap needle hub holds the needle and cartridge in a position and restricts the downward movement of cartridge initially and prevent penetration of needle in cartridge and blocks the accidental injuries during administration.