FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION:
MECHANISM FOR NEEDLE SHIELD REMOVAL FOR DRUG DELIVERY THROUGH PRE FILLED SYRINGE AND AUTO JET LOADED STARTER
KIT
2. APPLICANT (S)
(a) NAME: WOCKHARDT RESEARCH CENTRE
(b) NATIONALITY: INDIAN
(c) ADDRESS: D-4, M.I.D.C. AREA, CHIKALTHANA, AURANGABAD -
431210 (M.S) INDIA
3. PREAMBLE TO THE DESCRIPTION
A system and mechanism for removal of needle shield (25) of a pre filled syringe (24) containing a pharmaceutical substance loaded in a typical auto jet device (22, 27), which is packaged in a starter kit comprising claws that are curvedly projected and having edged surface at its distal end (3) mounted on starter kit body (1) internally, said claws are flexible enough to bend and regain their original position to sustain repeated usage, the said claws (3) being at least one, serving to firmly hold a auto jet device during its assemblage during loading of the pre filled syringe (24) into the auto jet bottom body by application of force ; the application of force exerted by pull of the assembled auto jet device results in the release of claws (3) from the auto jet device and hooking on to the needle shield cap (23) firmly at its base, and said above


force sufficient enough to simultaneous release of the needle shield (25) from the pre filled syringe (24).
The disassembled empty auto jet bottom body (22) after the administration of the pharmaceutical substance to a patient can be reinserted into the starter kit through auto jet bottom part holder (7) for subsequent use.
The following specification particularly describes the invention and the manner in which it is to be performed.
4 Description
The invention relates to a mechanism for needle shield removal in a auto jet and pre filled syringe loaded starter kit. Many needle safety shield devices have been reported in prior art that ensure protection, retraction of the safety shield during use, movement of shielded auto jet needle assembly from lock to unlock position, tubular portion telescopically disposed etc which have been cited below by reference.
US Patent 7,314,464 describes safety shield system for an injection device comprising a needle assembly and cap which provide for protection of both ends of a double-ended needle cannula after injection using the needle assembly and injection device.
US Patent 6,986,760 is related to safety shield system that permits retraction of the safety shield during use, but extends the shield enclosing the needle cannula in a locked position following use.
US Patent 5,931,817 relates to pen needle assembly that is used with an adaptor that is threaded onto a conventional medication delivery pen. Pen needle assembly includes a hub with a thread that attaches to the adaptor.


US Patent 5,873,462 invention relates to a pen needle dispenser and, more particularly, to an apparatus that holds and dispenses sterile pen needles for medication delivery pens and that safely stores the needles after use
US Patent 5,941,857 invention relates to disposable pen needle assembly prevents an unused shielded pen needle assembly from moving into a locked position within an outer cover, but permits a used unshielded pen needle assembly to snap lock into a locked position within the outer cover.
US Patent 5,591,133 relates to flexing safety shield for a needle that would gets displaced and retracted to original position.
US Patent 5,137,516 relates whereby the sleeve and container can be removed from the housing by cooperation with the administering device and can be returned to the housing after use.
US application US20050038392A1 relates to medication delivery pen assembly for self-administered injections, particularly with insulin, comprises needle assembly having shield having tubular portion telescopingly disposed about at least portion of hub.
US application US 20070293819 Al relates to safety shield system for needle cannula or pen injectors, comprises tubular clip having resilient fingers, tubular reciprocable shield and channel-shaped tracks.
US Patent 6,159,181, US applications 2003/0093036 and 2003/01050430 are mechanisms to shield the penetrating needle after use.
Needle shield are provided over the needle in a pharmaceutical substance pre filled syringe as a safety precaution to prevent any hurt or injury to the patient while using the syringe. If there is a repetitive self administration of the pharmaceutical substance by the patient it requires frequent handling of pre filled syringe leading to increased risk


exposure to hurt and injury. Hence this invention has developed a starter kit comprising pre filled syringe and auto jet device and a mechanism that allows the dislodging of the needle shield during the assemblage of the pre filled syringe and auto jet by application of manual force.
The administration of pharmaceutical substance could be a single dose pharmaceutical substance such as sumatriptan or sumatriptan succinate for acute treatment of migraine attacks.
The invention aims at provision of claws (3) and they are molded integrally on to the bottom surface of the starter kit body (1) circumferentially around the auto jet bottom part holder (7). Claws are more than one and four numbers in one of the embodiments. The chosen material for claw are flexible, strong and of such shape and dimension as to sustain the repetitive operation of the auto jet device without any difficulty. There could be several hundred operations of the auto jet device of the starter kit i.e one hundred or more operations. Chosen materials for claw could be inert polymeric materials of a natural or synthetic origin, for example acrylic plastics, styrene plastics, vinyl chloride plastic, poly acryl amide, polyester, polyamide, poly carbonate etc. Typical shape of the claw (3) is as shown in FIG 2.
Claws (3) not only function to retain auto jet bottom body (22) but also removal of the needle shield (25). One of the main functions of claws (3) is to facilitate removal and exit of the needle shield (25) of the pre filled syringe (24) while performing the tasks of insertion of the pre filled syringe on to the auto jet bottom body (22), attachment of auto jet top body (27) to auto jet bottom body (22) by mating of external thread (31) and internal thread (34) and pull out of the pre filled syringe inserted assembled auto jet device. Claws (3) perform this function by firmly gripping the auto jet device and more particularly the auto jet bottom body (22) during the insertion of pre filled syringe (24) and hooking on to the distal surface of the needle shield cap (23) by disengaging from the auto jet bottom body (22) on application of upward force for pull out of the auto jet device. The shape, dimension, number and the material of the claws are so determined that bending of claw associated while insertion of auto jet bottom body (22) into its


position through auto jet bottom portion holder entry (13) for the subsequent operation of the auto jet device and the pull out of the pre filled syringe assembled auto jet device does not weaken its functioning.
Details of various drawings are given below.
FIG1&FIG1-A
FIG 2
FIG 3
FIG 4
FIG 5
FIG 6
FIG 7
FIG 8
FIG 9
Perspective view of assembled starter kit
Cutaway view of the body showing claws and perspective view of
the middle section, associated parts and starter kit top
Starter kit top showing track to guide and hold the flanges
Starter kit body with pre filled syringe shield
Perspective view of Refill Pack
Perspective view of middle section showing hinge guide and hinge
button
Perspective view of a typical pre filled syringe
Perspective view of needle shield
Perspective view of auto jet top body showing knob lock & unlock
position
FIG 10 Perspective view of auto jet bottom body along with needle shield
cap in position
FIG 11 - A View after new PFS introduced to auto jet bottom body with
needle shield in place
FIG 11 - B View after application of force on PFS & attachment of auto jet top
body
FIG 11 - C View after assembly of auto jet top body and auto jet bottom body
Table Nomenclature
Starter kit means a kit comprising a starter kit body (1), a middle section (6), a typical auto jet device (22,27), a needle shield cap (23), a refill pack (28) comprising pre filled syringes (24) with needle shield (25), claws (3) that facilitate needle shield cap (23), a bottom hole for the exit of needle shield and which is provided with a hinged starter kit top (30) to access to the above components of the kit.


A typical auto jet device comprises two parts, the auto jet bottom body (22), i.e a syringe holding part and the auto jet top body (27) i.e press button part.
There are claws (3) molded integrally on to the bottom surface of the starter kit body (1) circumferentially around the auto jet bottom part holder (7). Claws are more than one. Claws are four numbers in one of the embodiments. The chosen material for the claws (3) are flexible and reversible, strong and of such shape and dimension as to sustain the repetitive operation of the auto jet device without any difficulty. There could be several hundred operations of the auto jet device of the starter kit i.e one hundred or more operations. Typical shape of the claw (3) is as shown in FIG 2.
One end of the claw (3) i.e the proximal end is integrally molded on to the bottom part of the starter kit body (1). The distal end of the claw has a curved projection and forms an edge like surface at its top most point. In the embodiment comprising four claws, the location of the four claws are such that curved projection at the distal end would face towards the centre point of the exit hole provided in the starter kit for needle shield exit.
Chosen materials for starter kit body (1), middle section (6), refill pack (28) and other parts of the starter kit are made of inert polymeric materials for example acrylo butyl sulphate (ABS), poly propylene co polymer (PPCP) etc
Claws (3) not only function to retain auto jet bottom body (22) but also removal of the needle shield (25). One of the main functions of claws (3) is to facilitate removal and exit of the needle shield (25) of the pre filled syringe (24) while performing the tasks of insertion of the pre filled syringe on to the auto jet bottom body (22), attachment of auto jet top body (27) to auto jet bottom body (22) by mating of external thread (31) and internal thread (34) and pull out of the pre filled syringe inserted assembled auto jet device. Claws (3) perform this function by firmly gripping the auto jet device and more particularly the auto jet bottom body (22) during the insertion of pre filled syringe (24) and hooking on to the distal surface of the needle shield remover (23) by disengaging


from the auto jet bottom body (22) on application of upward force for pull out of the auto jet device. The shape, dimension, number and the material of the claws are so determined that bending of claw associated while insertion of auto jet bottom body (22) into its position through auto jet bottom portion holder entry (13) for the next operation of the auto jet device and the pull out of the pre filled syringe assembled auto jet device does not weaken its functioning.
A refill pack (28) comprises two compartments each of which accommodates one pre filled syringe (24)
Starter kit comprises starter kit body (1), middle section (6), starter kit top (30), refill pack (28), claws (3) provided adjacent to the auto jet bottom part holder (7) of the bottom of the starter kit body (1) circumferentially, auto jet top body (27) & auto jet bottom body (22).
Starter kit top (30) along with track to guide and hold the hinges (19) are molded integrally. Starter kit body (1) along with claws (3), and embossed enhancer (5) are molded integrally. Refill pack (28) comprising PFS container cap (17) and PFS container body (16) are molded integrally. Middle section (6) comprising auto jet bottom part holder (7), mold section flange (14) locking groove (12), hinges (15), hinge guide (10) & hinge button for locking (11) are molded integrally. Starter kit top (30) can be opened and closed over hinges (15). Locking projections (2) of starter kit body (1) mates with locking groove (12) of middle section (6). Pre filled syringes (24) can be removed from the PFS container body (16) by opening and closing of PFS container cap (17).
Claws (3) are molded integrally on to the starter kit body. Starter kit top (30) is hinged on to the starter kit body (1) through a track to guide & hold the hinges (19) and hole for the hinge button lock (20). This firmly secures the starter kit contents and also helps in the frequent opening and closing.


Auto jet top body (27) comprises a knob (21) provided at the proximal end and external thread (31) provided at the distal end. Auto jet top body (27) has external thread (31) that mates with the auto jet bottom body (22) internal thread (34). Further knob lock position (32) & knob unlock position (33) have been provided on the auto jet top body (27) at the proximal end. Knob lock position (32) ensures the safety of the auto jet device accidentally going off at the time of its first use. FIG 2 & FIG 9 depict the details.
Auto jet bottom body (22) has internal thread (34) provided at its proximal end and a provision for insertion of tapered needle shield cap (23) at its distal end, a hollow guide (29) & a spring (35). The spring is secured in between the hollow guide (29) and the auto jet bottom body (22) at its distal end and its ends are secured to auto jet bottom body (27) and hollow guide (29). This ensures flexible vertical movement of the hollow guide (29). Needle shield cap (23) fits on to the auto jet bottom body (27) as depicted in FIG 10.
A typical pre filled syringe (PFS) comprises a syringe (24), a needle shield (25) and an integrally bonded needle (26) as depicted in FIG 7.
Figure 2 is a perspective view of to be assembled starter kit with components in respective locations ready for use. Auto jet top body (27) is located inside the starter kit through a auto jet top portion guide (9) of middle section (6) as to have the knob (21) portion near the proximal end or the starter kit top (30) and external thread (31) and plunger (36) distally or away from it. Auto jet bottom body (22) is located inside the starter kit through a auto jet bottom portion holder entry (13) as to have the internal thread (34) portion proximally or near the starter kit top (30). The claws (3) provided on the bottom portion of the starter kit body are such that it firmly grips the auto jet bottom body (22) portion. Needle shield cap (23) is provided at the auto jet bottom body. Refill pack (28) has two compartments, both of which have one pre filled syringe each.
FIG 11 depicts the perspective view of the location of pre filled syringe (24) & needle shield (25), from the instance of commencement of usage of the auto jet device from the starter kit till the exit of the needle shield (25).


The usage of the starter kit starts by opening of the hinged starter kit top (30 ) provided on the starter kit body (1). Pre filled syringe (PFS) (24) provided in one of the PFS container bodies (16) is taken out by opening the hinged starter kit top(30) PFS container cap (17). Pre filled syringe (24) is inserted in to the auto jet bottom body (22). The outer diameter of the pre filled syringe (24) and the outer diameter of the needle shield (25) are smaller than the inner diameter of the hollow guide (29) as to allow it pass through. PFS syringe (24) is provided with a flange which sits on top of the hollow guide (29). Figure 11 depicts the operation of a typical auto jet device (22, 27) and a typical needle shield (25) pre filled syringe (24) provided in the starter kit.
FIG 11 - A shows the view after new PFS (24) in position to auto jet bottom body (22) with needle shield cap (23) in place. The auto jet bottom body (22) is firmly held by four claws (3) on its outer surface at its distal end. The narrow tapered needle shield cap (23) has its lower diameter end away from the distal end of the auto jet bottom body (22) and its other end has a flange and almost corresponds to outer diameter of the distal end of the auto jet bottom body (22). Further, the outer diameter of the flexible needle shield (25) is such that it would make a tight fit onto the tapered end of needle shield cap (23) so as to allow its entry into it through a very narrow distance in the proximal portion of the needle shield cap (23) ( say not more than half of the length of the needle shield cap (23) at the most). Claws (3) are still firmly held on to the auto jet bottom body (27) at its distal end at this stage.
The next step would be to apply pressure manually on top of the pre filled syringe (24) so that the needle shield (25) moves fully inside the needle shield cap (23). The position of the distal end of the needle shield (25) would almost correspond to the distal end of auto jet bottom body (22).
FIG 11 - B shows the view after application of force on pre filled syringe (24). At this point of time, normal pulling of the needle shield cap (23) from the bottom auto jet


bottom body would not result in exit of the needle shield cap (23) but would ooze out to a certain distance as an elastic substance would do and retains its original position on release. Force needs to be applied to dislodge the contact between the needle shield (25) and the needle shield cap (23). This is due to firm gripping between the needle shield (25) and the needle shield cap (23) at the proximal portion of the needle shield cap (23). Further, force is required to dislodge the contact between auto jet bottom body (22) and the claws (3) which hold it.
Auto jet top body (27) is taken out of auto jet top portion guide (9) and screwed on to auto jet bottom body (22) as shown in FIG 11 - C
At this point of time, pre filled syringe assembled auto jet device is pulled out of the auto jet bottom part holder (13). Force applied to pull it out would be sufficient to break the contact between the auto jet bottom body (22) and the claw (3) and consequently claws firmly hook on to flanged surface at the distal end of the needle shield cap (23). Also the force pull out of the auto jet device would suffice to break the contact between the needle shield (25) and the needle shield cap (23) and the needle shield (25) falls out of the bottom hole.
The auto jet device is now ready for administration of pharmaceutical substance present in the pre filled syringe (24) to the patient but with a safety feature of the knob (21) in the locked position. Pharmaceutical substance is administered to a patient after shifting the knob (21) to unlock position and the used pre filled syringe is discarded. Auto jet top body (27) and auto jet bottom body (22) are unscrewed. Auto jet top body (27) is put back into its position through auto jet top portion guide (9) after shifting the knob (21) into lock position. Auto jet bottom body is inserted back to the starter kit through auto jet bottom part holder (7). There is a provision for a new pre filled syringe (24) to be inserted into refill pack (28). Subsequently starter kit top (30) is closed.


We claim :
1 A system and mechanism for removal of needle shield (25) of a pre filled syringe
(24) containing a pharmaceutical substance loaded in a typical auto jet device
(22, 27), which is packaged in a starter kit comprising claws that are curvedly
projected and having edged surface at its distal end (3) mounted on starter kit
body (1) internally, said claws are flexible enough to bend and regain their
original position to sustain repeated usage, the said claws (3) being at least one,
serving to firmly hold a auto jet device during its assemblage during loading of
the pre filled syringe (24) into the auto jet bottom body by application of force ;
the application of force exerted by pull of the assembled auto jet device results in
the release of claws (3) from the auto jet device and hooking on to the needle
shield cap (23) firmly at its base, and said above force sufficient enough to
simultaneous release of the needle shield (25) from the pre filled syringe (24).
The disassembled empty auto jet bottom body (22) after the administration of the pharmaceutical substance to a patient can be reinserted into the starter kit through auto jet bottom part holder (7) for subsequent use.
2 A system and mechanism according to claim 1, wherein the pre filled syringe is a single use unit.
3 A system and mechanism according to claim 1, wherein the pharmaceutical substance is Sumatriptan or a salt thereof.
4 A system and mechanism according to claim 1, wherein the claws (3) are mounted integrally and circumferentially around the auto jet bottom portion holder (7) of starter kit body (1).


5 A method of using a system and mechanism according to claim 1, comprising
removal of pre filled syringe (24) from refill pack (28) and insertion into the auto
jet bottom body (22)
6 A system and mechanism according to claim 1, wherein the auto jet top body (27) is screwed on to auto jet bottom body (22) which results in assembled auto jet device
7 A system and mechanism according to claim 1, wherein the application of force by pull on assembled auto jet device as per claim 7 results in release of assembled auto jet device from the claws and makes it ready for pharmaceutical substance administration.
8 A system and mechanism according to claim 1, wherein the exit of needle shield (25) through bottom hole of auto jet bottom part holder (7) occurs as per claim 7
9 A system and mechanism according to claim 1, wherein the claws (3) hook on to needle shield cap (23) as per claim 8
10 A system and mechanism substantially as herein described.




Abstract
Needle shield is provided over the needle in a pre filled syringe containing pharmaceutical substance as a safety precaution to prevent any hurt or injury to the patient while using the syringe. If there is a repetitive self administration of the pharmaceutical substance by the patient it requires frequent handling of pre filled syringe leading to increased risk exposure to hurt and injury. Hence this invention has developed a starter kit comprising pre filled syringe and auto jet device and a mechanism that allows the dislodging of the needle shield during the assemblage of the pre filled syringe and auto jet device by application