Abstract
A syringe is disclosed, comprising: an outer casing or syringe housing with finger pads or finger rings at the proximal end capable of firmly holding; a cartridge having a glass or plastic barrel or generally tubular barrel with a cap assembly comprising of a needle pierceable septum or sealing element held by a ferrule or crimp at the distal end of the barrel and a stopper/piston disposed at the proximal end of the barrel to contain the medicament or other formulation between the stopper/piston member and the septum or sealing element, a plunger rod with finger pad or finger ring at one end and in communication with the cartridge stopper/piston at the other end, wherein the cartridge is held axially in a fixed or in a first position and is prevented from substantially moving or moving unaided axially forwards or backwards within the syringe housing.
Claims
1. A syringe comprising: an outer casing or syringe housing with finger pads or finger rings or a mixture of at the proximal end capable of firmly holding: a cartridge having a generally tubular glass or plastic barrel with a cap assembly comprising of a needle pierceable septum or sealing element held by a ferrule or crimp at the distal end of the barrel and a stopper/piston disposed at the proximal end of the barrel to contain the medicament or other formulation between the stopper/piston member and the septum or sealing element, a plunger rod with finger pad or finger ring at one end and in communication with the cartridge stopper/piston at the other end, and a double needle comprising a septum needle and an injection needle, wherein said septum needle projecting from the distal end of the syringe housing into the interior of the syringe housing is rigidly held in the syringe housing, wherein the cartridge can be moved axially forward by the user to a position wherein the cartridge septum is perforated by the septum needle establishing fluid communication between the cartridge contents and the nozzle or connector, characterized in that, said injection needle is separate from said septum needle and said septum needle is in fluid communication with a connector means to which said injection needle is attachable in order to establish fluid connection of said septum needle to said injection needle.
2. The syringe of claim 1, wherein said means to establish fluid connection of said septum needle to said injection needle is one of a transfer nozzle or a connector selected from among a tip, catheter tip, coiled tip, eccentric tip, intravascular line connector, luer slip or lock, or a threaded connector.
3. The syringe of claim 1, wherein the septum needle is of greater diameter or smaller gauge number than the injection needle.
4. The syringe of claim 1 wherein the plunger rod has a number of axial and radial slots or grooves in communication with one another and in engagement with a pin connected to the syringe housing for providing a dosing system, wherein the length of an axial slot limits how far the rod can be pushed, thereby determining the exact dose of a drug to be delivered.
5. The syringe of claim 1 wherein a number of gas-access pathways are provided in the syringe housing to facilitate gas sterilization of the septum needle.
6. The syringe of claim 1 wherein the syringe has a needle cap to cover the nozzle or connector or tip or to cover the means to attach a needle prior to use.
7. The syringe claim 1 wherein the syringe has a needle safety guard with finger flanges or finger grips that can be used to cover the injection needle after use.
8. The syringe of claim 1 wherein the cartridge is held in the first position by a locking mechanism on the cartridge shoulder or cap at the cartridge distal end that can be unlocked by a manual switch or lever or any other means so that the cartridge can be pushed to the second position.
9. The syringe of claim 1 wherein a ring is used to lock the cartridge at the first position before use wherein the ring is rotatable relative to the outer casing or housing or movable axially relative to the syringe housing to release the locking mechanism wherein the locking mechanism is formed as part of the housing or is attached to the housing and wherein the lock is held in the locked position by the ring.
10. The syringe according to any one of the preceding claims of claim 1 wherein a sleave or a needle shield cap with finger flanges or grips is used to lock the cartridge at the first position before use wherein the sleeve is movable axially relative to the syringe housing to release the locking mechanism wherein the locking mechanism is formed as part of the housing or is attached to the housing and wherein the lock is held in the locked position by the sleave.
11. The syringe according to of claim 1 wherein the safety guard with finger flanges or grips is used to lock the cartridge at the first position before use wherein the sleeve is movable axially relative to the syringe housing to release the locking mechanism wherein the locking mechanism is formed as part of the housing or is attached to the housing and wherein the lock is held in the locked position by the safety guard.
12-13. (canceled)
14. The syringe of claim 1 wherein the filled cartridge is inserted into the syringe housing by the user.
15. The syringe of claim 1 wherein the filled cartridge is delivered to the user inserted into the syringe housing and wherein the syringe and cartridge combination are terminally sterilized.
16. The syringe of claim 14 wherein the cartridge septum and injection needles or nozzle, tip or connector are isolated from the environment by a sterile assembly comprising one or more seals in between the syringe housing and the cartridge barrel wherein the seal(s) are fixed to the syringe housing and one or more seals in between a cap and the syringe housing wherein the seal is fixed to the cap or to the syringe housing, wherein either the terminal sterilization is done using radiation and wherein the syringe materials and cartridge contents are compatible with the radiation used to ensure all the required syringe parts are fully sterilized; or wherein the terminal sterilization is done using gas or vapor and wherein the syringe materials and cartridge contents are compatible with the gas or vapor and the temperature used and wherein there are sufficient gas or vapor pathways and wherein sufficient syringe parts are gas or vapor permeable to ensure all the required syringe parts are fully sterilized.
17-20. (canceled)
21. The syringe of claim 1 wherein the plunger rod has a guide with two or more wings or arms that fits into the cartridge by interference fit so that the plunger rod remains in place and stable during transport or handling wherein the friction between the plunger rod wings and the internal walls of the cartridge can easily be overcome by the user when pressing the plunger rod during operation.
22-37. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0074] Various embodiments of the present invention, by way of example, are provided in the figures. Therein,
[0075] FIG. 1 shows a state of the art standard ISO 13926 Cartridge.
[0076] FIGS. 2 shows the basic invention and prior art.
[0077] FIGS. 3 shows the functioning of the basic invention and prior art with a removable needle cap.
[0078] FIGS. 4 show terminal sterilization options.
[0079] FIG. 5 shows the prior art with a cartridge holding feature.
[0080] FIG. 6 shows a further embodiment of the invention with a cartridge holding feature.
[0081] FIGS. 7 show further embodiments of the invention with a cartridge locking feature as part of a needle cap that when removed unlocks the cartridge and releases the cartridge ready for use.
[0082] FIG. 8 show further embodiments of the invention with a cartridge locking feature as part of the syringe housing with a needle cap that when removed unlocks the cartridge and releases the cartridge ready for use.
[0083] In FIGS. 9 a needle stick injury prevention sleave is shown.
[0084] In FIGS. 10 an integrated precise dosing mechanism is shown.
[0085] In FIGS. 11 various cartridge lock embodiments are shown.
[0086] In FIGS. 12 a dual chamber cartridge option is shown.
[0087] FIGS. 13 show further embodiments of the invention with a cartridge locking sleave with finger pads.
[0088] FIGS. 14 show further embodiments of the invention with a cartridge locking sleave combined with a needle shield or guard with finger pads.
[0089] FIGS. 15 show a further embodiment of the invention with needle hub.
[0090] FIGS. 16 show a further embodiment of the invention with needle hub with a sterile assembly.
[0091] FIGS. 17 show a further embodiment of the invention with needle hub and a needle cap and actuator.
[0092] FIGS. 18 show a further embodiment of the invention with needle hub and a screw off cap and actuator.
[0093] FIGS. 19 show a further embodiment of the invention with a plunger rod incorporating a cartridge mating feature.
[0094] FIGS. 20 shown further embodiments of the invention with cartridge inserted into the syringe housing.
[0095] Generally, identical parts are provided with the same reference numbers in all figures. The invention will be explained below primarily with reference to the embodiments shown. However, other embodiments are of course also conceivable and covered by the present invention.
DETAILED DESCRIPTION OF THE DRAWINGS
[0096] In FIG. 1 a cartridge 110 has a plastic or glass barrel 111, an open end 119 and a necked 113 and flanged end 113b at a distal end forming a shoulder 113a with the barrel. A movable stopper plunger 112 at open end 119 and a rubber cap assembly 95 at the necked end or distal end 113 seal the drug formulation solution 117 within the barrel 111. Cap assembly 95 has a septum 114 which is held in place by a metal crimp or ferrule 115 which is in turn crimped to the cartridge neck 113. Ferrule 115 has a hole 116 to allow needle insertion through the septum 114.
[0097] Such cartridges are fully described in ISO 13926 and can have glass or plastic barrels.
[0098] In the following Figures the cap 95 refers to the combination of a ferrule and a septum assembly as described in FIG. 1.
[0099] FIG. 2a shows the syringe system of the prior art. A cartridge 110 is mounted within a casing or housing 127 at a first position. A double needle comprising an injection needle 123 and a septum needle 124, the two needles in fluid communication, is firmly held at the front end of housing 127. Cartridge 110 is axially free to move under user force in the direction of the septum needle 124 to a second position and when axially pushed it forces septum needle 124 to pierce the cartridge cap 95 enabling the syringe system ready for injecting.
[0100] The user can push the plunger rod 128 using the thumb or finger pad 129 and finger flanges 131 in the usual way to axially push the cartridge 110 to a second position to enable the syringe system and prime the system if required and perform the injection of contents 117 via injection needle 123.
[0101] Needles 123 and 124 may be separate needles of different gauges or formed from a single needle with two sharp beveled ends. The injection needle may have a blunt end. It may have one or more bends. Needles 123 and 124 may be separate needles and the septum needle 124 may be of a larger diameter or smaller gauge compared to the injection needle 123 to minimize the force required to inject viscous formulations. The two needle ends may have different bevel arrangements. Injection needle 123 may be a nozzle for connection to another device or system or a connector such as a luer connector for connecting an injection needle. In the prior art plunger rod 128 is firmly attached to stopper 112.
[0102] In the current invention gas-access pathways 135 are placed in casing 127 to facilitate gas sterilization of the needle assembly.
[0103] In the present invention the plunger rod 128 may or may not be attached to the stopper 112. Where no plunger pull back is desirable or must be avoided the plunger rod 128 is not attached to stopper 112 and accordingly in the present invention plunger rod 128 may be firmly but slidably held within the cartridge barrel 111 but not attached to the stopper 112. This is shown in FIGS. 19.
[0104] FIG. 2b shows the prior art and the present invention with finger pads 129 and 131 of FIGS. 2a replaced with rings 129a and 131a for easier stopper 112 pull back when required.
[0105] Note that in FIGS. 2 injection needle 123 maybe sized for any application including for subcutaneous, intramuscular or intradermal injections. Additionally, instead of needle 123 a connector or nozzle or other fitting type may be used depending on the requirement including luer slips or locks for hypodermic needles and catheter tips or eccentric tips for infusion lines or other applications. Unlike in pre-filled syringes in the present invention the connectors or needles are part of the syringe housing not of the primary pack making it easier to supply the syringe with any connector or needle type. Changing primary packs such as syringes or cartridges for different connectors or needles is very time consuming, costly and risky. Not having to do so in the present invention is a great innovation.
[0106] Note that casing 127 may be made of a transparent material or have viewing windows or holes in order that the user may inspect the cartridge drug contents before and even during use.
[0107] FIGS. 3 further describe the basic mechanics of the invention and some prior art. In FIG. 3a the syringe system 122 has a cartridge 110 free to move axially within casing 127 under user force and is shown in FIG. 3a at a first position. In FIG. 3b the cartridge is shown in a second position and septum needle 124 has pierced cap 95. To go from a first position shown in FIG. 3a to the second position shown in FIG. 3b the user uses finger flange 131 and thumb pad 129 in the usual way and pushes/pulls in the direction as shown by arrows 161 and 162 in FIG. 3b. In FIG. 3c the syringe system has been primed and the stopper/piston has been moved or primed to the optional dose indication mark 145 before the injection for an accurate volume injection.
[0108] Note that the injection can take place all in one stroke with the needle being firstly inserted into the injection site and then the plunger rod pushed. This first pushes the cartridge forwards to perforate septum and is followed by the injection itself. All in one user stroke.
[0109] FIGS. 3a and 3b show an optional gas or air bubble 118 which has been removed after priming in FIG. 3c. In some applications an air bubble is advantageous for instance for suspensions. In some other applications it is not desirable.
[0110] In FIG. 3a an optional cap 181 may be made from gas permeable material or have gas pathways for gas sterilization in a blister and is removed by the user before the injection.
[0111] FIGS. 4 show two options for terminally sterilizing the syringe system of the present invention. The cartridge 110 is shown in a first position.
[0112] In FIG. 4a the syringe system 121 has a cap 192 or a gas permeable cap 192 for gas sterilization. Cap 192 is sealed against the casing 127 by one or more seals 195 which can be part of cap 192 or part of syringe housing 127. To ensure the needles 123 and 124 and the septum 116 remain sterile after sterilization the barrel 111 of cartridge 110 is additionally sealed against casing 127 by one or more seals 196 which are fixed and securely held in syringe housing 127. Note that gas-access pathway(s) 135 are also coved by the gas permeable cap 192 and that there are sufficient gas pathways to fully terminally gas sterilize the needles and cartridge septum. The gas pathways are covered by the gas permeable needle cap to allow gas in and seal the gas pathways from foreign matter.
[0113] Depending on the drug formulation type the system may be sterilized using radiation such as E beam or Gama rays. In this case gas pathways 135 are not required and the cap 192 need not be gas permeable. The great advantage of the present invention when compared to U.S. Pat. No. 10,561,793 are that the seal(s) 196 are fixed to syringe housing 127 and stationary. Additionally, unlike U.S. Pat. No. 10,561,793 no aseptic assembly is required to keep the septum and needles sterile as the whole syringe system in terminally sterilized.
[0114] In FIG. 4b the syringe system 120 with filled cartridge 110 is placed blister 132 for sterilization and ensure the needles 123 and 124 and the septum 116 remain sterile. If gas sterilization is used a gas permeable blister is used. An optional needle cap may be added but is not shown which if gas sterilization is used must be gas permeable.
[0115] Depending on the drug type and the packaging and device materials the drug filled system shown in FIGS. 4a and 4b may be sterilized using moist heat (steam), dry heat, gamma radiation or other radiation, ethylene oxide gas, vaporized hydrogen peroxide, chlorine dioxide gas, vaporized peracetic acid, nitrogen dioxide or by any other method.
[0116] Where gas or vapor sterilization is used there must be sufficient gas pathways to fully gas sterile the needles and cartridge septum. The gas pathways are covered by the optional gas permeable needle cap when used to allow gas in during sterilization.
[0117] The syringe system shown in FIGS. 4b may also be sterilized without the cartridge 110 inserted or in place in which case the cartridge is inserted by the user. It is advisable that the user wipes the cartridge septum with alcohol before assembly.
[0118] In FIG. 5 a means of holding the cartridge in a first position is shown as generally described in the prior art such as U.S. Pat. No. 4,834,717. A syringe 122a has a cartridge 110 with drug solution 117. Cartridge 110 is held in place at a first position by a deformable stop 216. Stops 216 prevents cartridge 110 from moving towards septum needle 124 before the user uses the device by pressing on the plunger pad 129. The deformable stop 216 may be located against the cartridge shoulder as shown in FIG. 5 or alternatively against the cartridge cap 95. In U.S. Pat. No. 4,834,717 the stops 216 are hard molded plastic ribs. In the present invention the deformable stops 216 may be an elastomeric O ring or other deformable feature.
[0119] In FIG. 6 another means of holding the cartridge in a first position is shown. A syringe 122b has a cartridge 110 with drug solution 117. Cartridge 110 is held in place with one or more friction pads 217. The cartridge is frictionally held in the syringe housing by pads 217 pressing against the cartridge barrel so that when the user presses the plunger rod the force required to move the cartridge towards the needle is similar to the force required to perform the injection or push the liquid drug formulation out via the needle. In this arrangement unlike in arrangement shown in FIG. 5 there is no sudden change in the forces required for operation between pushing the cartridge forward and injecting the drug. The friction pads 217 maybe for instance be formed by one or more elastomeric O rings or be molded as part as the syringe housing 127. Such an arrangement can be used in addition to those shown in FIGS. 7 and 8.
[0120] In FIG. 7a another embodiment of the present invention is shown. Means of locking the cartridge in a first position is shown. A syringe 122c has a cartridge 110 held in a first position before use by locking tabs 212 formed as part of a needle cap 181 that protrude though through openings 212a in syringe housing 127. Cap 181 may be made of a soft elastomeric material in which case tabs 212 can be formed as part of the cap. Alternatively cap 181 maybe made of a hard plastic with either a soft elastomeric tab 212 attached or tabs 212 may be formed in a hard plastic and hinged and capable of lifting out of the way when cap 181 is pulled off by the user releasing cartridge 110 as additionally shown in FIG. 7b.
[0121] In FIG. 7b a cap 181 has locks tabs 181a. This cap is for use the embodiment shown in FIG. 7a. Cap 181 is split into two or more parts by slits 181c. When cap 181 is pulled off by the user the lock tabs 181a bend outwards allowing cap removal. Lock tabs 181a are angled to facilitate removal from the syringe housing.
[0122] In FIG. 8 a cartridge locking mechanism is shown as generally described in U.S. Pat. No. 10,603,439. A syringe 122d has a hinged lock or flexible locking tabs 214 formed as part of or attached to syringe casing 127 locking the cartridge 110 in a first position before use. Lock 214 is prevented from moving by needle cap 187 before use. Once cap 187 is removed by the locks or tabs 214 can move radially away from the cartridge 110 when the user presses plunger pad 129 allowing the cartridge 110 to move forward to a second position where the needle 124 perforates the cartridge septum ready for injecting.
[0123] It must be noted that in the present invention the lock 214 may be alternatively held by a button or a switch or a ring and independently from the cap 187. Additionally, instead of cap 187 removal it may be release by cap 187 rotation or by a ring rotation independently from the cap 187.
[0124] In FIG. 8 hinged lock 214 maybe have a normally in position or spring loaded and biased towards the locked position as described in U.S. Pat. No. 10,603,439. In the present invention the hinged lock may be of a normally out position or spring loaded and biased towards the unlocked position. Being in the normally out position has the great advantage that the user does not need to overcome the lock with plunger force leading to a smoother injection stroke.
[0125] In FIGS. 9a and 9b another feature of the present invention is shown. Device 301 has a safety sleeve 810 held over a syringe body 127 that is frictionally held in place as shown in FIG. 9a before the device is used. A spring-loaded latch 812 is located in the sleeve 810 and this may be used to frictionally hold the sleeve 810 in place before use. Note that the spring-loaded latch 812 may be a simple plastic feature molded as part of the sleeve 810 or a made of separate parts and more than one latch 812 may be used. Sleeve 810 also has at least one viewing window 817 or be transparent allowing the user to inspect the drug formulation before use through viewing windows 127a of syringe housing 127. A groove 818 facilitates the safety sleeve to pass over the lock 214 when pushed by the user to the locked position as shown in FIG. 9b
[0126] In FIG. 9b device 301 is shown after use. Cartridge contents 117 have been expelled via needle 123 by pressing plunger pad 129 and the safety sleeve 810 has been pushed forward by the user covering needle 127 to prevent needle stick injuries after use. Spring loaded latch 812 has snapped into recess 814 in syringe housing 127 locking safety sleeve 810 into place.
[0127] FIGS. 10 show yet another embodiment of the invention with an accurate dosing system. Device 302 is shown before use in a first position in FIG. 10a. It is shown during use with the cartridge in a second position in FIGS. 10b and 10c. The device of FIGS. 10 has an accurate dosing mechanism 331, 332, 333, 336 ideally suited for very small doses.
[0128] In FIGS. 10 pin 336 which is attached to body 127 is firstly engaged in slot or groove 331 which is formed in plunger rod 128 as shown in FIG. 10a. As plunger rod 128 is pushed towards the cartridge 110 as shown by arrow 341 it moves until pin 336 reaches slot 332 and cannot move further. This second position is shown in FIG. 10b. During this movement of the plunger rod 128 the cartridge 110 moves forward from first position to second position and the needle 124 pierces the cartridge septum and the air bubble 118 (if present) and some liquid contents are expelled from device via injection needle 123 priming the device.
[0129] In FIG. 10c the injection has taken place. To get from FIG. 10b to FIG. 10c first the plunger rod 128 is rotated as shown by arrow 342 so that pin 336 engages with slot 333. The plunger rod 128 is then pushed as shown in arrow 343. As plunger rod 128 is pushed towards the cartridge 110 as shown by arrow 343 it moves until pin 336 reaches the end of slot 333 and cannot move further administering the exact dose of drug formulation determined by the length of slot 333.
[0130] Note that the position of the slots and pin may be reversed with slots 331, 332 and 333 formed in casing 127 with the pin 336 forming part or attached to plunger rod 128. More than one injection slot may be used with a rotation between them so that more than one exact dose of drug can be administered making a multi-dose syringe.
[0131] If the cartridge is filled without an air or gas bubble and priming is not required, the first slot 331 can be used only for moving the cartridge forward to the second position ready for injection.
[0132] FIG. 11 shows various alternative embodiments where the cartridge lock 214 is held in the locked position by a ring 413, 415 instead of the cap 187. FIG. 11a shows the same embodiment as FIG. 8 where the cap 187 prevents the lock 214 opening. FIGS. 11b to 11e show alternatives. In FIG. 11b the cartridge lock 214 is prevented from opening by ring 413 and not by cap 411. In FIG. 11c the ring 413 has been moved down in the direction of arrow 431 freeing the cartridge lock 214.
[0133] In FIG. 11d again the cartridge lock 214 is prevented from opening by ring 415 and not by cap 411. In Figure Ile ring 416 has been rotated as shown by arrow 433 aligning hole 416 in ring 415 freeing lock 214. In FIGS. 11d and 11e the injection needle has been replaced by a luer or other connector 471 in fluid communication with septum needle 124. This can be a luer slip or a luer lock connection for a hypodermic needle or a catheter tip or an eccentric tip or any other connector for intravenous infusions or other uses.
[0134] The ring 415 of FIG. 11d and 11e may be part of cap 411 in which case the cap 411 is rotated to release the cartridge and pulled to expose the injection needle, luer or other connector.
[0135] The arrangement shown in FIGS. 11 is particularly suited for use with a double chamber cartridge. This is shown in FIGS. 12.
[0136] In FIG. 12a the syringe has a dual chamber cartridge 510 which has two chambers divided by stopper 412. Chamber 511 contains a dilutant or a liquid drug formulation while chamber 512 contains a dry powder drug or lyophilized drug or a liquid drug formulation. Cartridge lock 214 is prevented from opening by ring 413. A bypass 419 connects the two chambers and is blocked or closed by stopper 412.
[0137] In FIG. 12b the ring 413 has been moved down in the direction of arrow 431 freeing the cartridge lock 214.
[0138] In FIG. 12c the plunger rod 129 has been pressed as shown in arrow 437. Cartridge 510 has moved forward and the cartridge septum has been perforated. Further pushing plunger rod 129 has moved stopper 112 forward. Because of the liquid stored in chamber 511 stopper 412 has also moves forward opening bypass 419 forcing the liquid in chamber 511 to enter chamber 512 mixing with the contents of chamber 512. Any air trapped in chamber 512 has been forced out via the needles.
[0139] In FIG. 12d the cap 411 has been removed and the mixed contents in chamber 512 have been injected via injection needle 123.
[0140] The cartridge locking may be done also by a cap that is first rotated to unlock cartridge before removing it for the injection. Ring 413 can also be rotated instead of pulled down to release the lock.
[0141] In FIGS. 13 another embodiment of the present invention is shown where a lock 215 is held in place by a sleave 450 that has finger pads or flange 449. To unlock the cartridge and proceed with the injection finger pads 449 and 129 are respectably pulled and pushed as shown by arrows 441 and 442.
[0142] In FIGS. 14 another embodiment of the present invention is shown where a lock 215 is held in place by a sleave and needle shield or cap 455 that has finger pads or flange 449. To unlock the cartridge and proceed with the injection finger pads 449 and 129 are respectably pulled and pushed as shown by arrows 441 and 442 as shown in FIG. 14b. Shield 455 may also be a needle safety guard and can be moved back and locked into place to cover the needle after the injection.
[0143] FIGS. 15 show the prior art as generally described in U.S. Pat. No. 10,561,793 but without the complex sterile assembly shown in U.S. Pat. No. 10,561,793.
[0144] In FIG. 15a syringe system 303 has a syringe housing 127 rigidly holding cartridge 110 within. Cartridge 110 has a cap assembly 95 at the distal end and a plunger rod 128 with thumb pad 129 at the proximal end. Attached to the syringe housing and opposite the cartridge cap 95 and free to move axially within is a needle hub 125 holding a septum needle 124 and an injection needle 123 in fluid communication with one another.
[0145] According to the present invention the syringe system shown in FIG. 15a is sterilized in a sealed blister 132 with or without the filled cartridge in place. For gas sterilization gas pathways 135 facilitate the circulation of gas during sterilization.
[0146] FIG. 15b the syringe has been removed from the blister 132 and the injection has taken place. The hub 125 has been moved towards the cartridge, the cartridge septum has been pierced by the septum needle 124 and the cartridge drug contents have been delivered through the injection needle 123.
[0147] FIGS. 16 also show the prior art as generally described in U.S. Pat. No. 10,561,793 but with a vital usable improvement with a simple design and where the syringe system is designed to be terminally sterilized.
[0148] In FIG. 16a syringe system 304 has a syringe housing 127 rigidly holding cartridge 110 within. Cartridge 110 has a cap assembly 95 at the distal end and a plunger rod 128 with thumb pad 129 at the proximal end. Attached to the syringe housing and opposite the cartridge cap 95 and free to move axially within is a needle hub 125 holding a septum needle 124 and an injection needle 123 in fluid communication with one another. Seals 171 between cartridge 110 and syringe housing and seals 172 in between the needle cap 417 and the syringe housing 127 seal the needles and the cartridge septum and keeps them sterile. The syringe system is terminally sterilized. If gas sterilization is used cap 417 is gas permeable.
[0149] FIG. 16b the needle cap 417 has been removed and the syringe has been used. The hub 125 has been moved towards the cartridge, the cartridge septum has been pierced by the septum needle 124 and the cartridge drug contents have been delivered through the injection needle 123.
[0150] FIGS. 17 show an embodiment of the invention that facilitates the usage of the syringe systems shown in FIGS. 15 and 16. In FIG. 17a a syringe system 311 has a needle cap and actuator 141 is sleaved over syringe housing 127 covering injection needle 123. The finger pads 931 are attached to actuator 141. Operation is shown in FIG. 17b where the user has pressed plunger pad 161 and puled finger pads 931 as indicated by arrows 161 and 162. The needle hub has engaged with actuator 141 and been pushed towards the cartridge and septum needle 124 has perforated cartridge septum ready for injection. FIG. 17c shows the syringe system halfway through delivering the cartridge formulation 117.
[0151] The needle cap and actuator 141 in FIGS. 17 may also be used as a safety needle guard and pushed back over the needle and locked into place by the user after the injection.
[0152] FIGS. 18 show an alternative embodiment of the invention where a syringe system 313 has a needle cap 202 with a shoulder 207 that engages and pushes needle hub 125 towards the cartridge septum by engaging with a screw thread 204 when rotated by the user as shown by arrow 205 in FIG. 18a. Once fully rotated the cap is removed by the user as shown by arrow 206 in FIG. 18b. In FIG. 18c the syringe system is ready to inject.
[0153] An additional needle safety guard may be added to the syringe system 313 shown in FIGS. 18.
[0154] In the syringe system 303 shown in FIGS. 15, the syringe system 304 shown in FIGS. 16, the syringe system 311 shown in FIGS. 17, and the syringe system 313 shown in FIGS. 18, the cartridge 110 may be held in position in the syringe housing 127 by interference fit between the cartridge barrel and syringe housing or firmly by the cartridge neck or cap at the cartridge distal end and at the cartridge proximal end.
[0155] FIGS. 19 show another embodiment of the invention where the syringe system 314 has a plunger rod 128 attached to a plunger rod guide 603. Plunger rod guide 603 has two or more wings or arms 607 that are flexible or are spring loaded and press against the internal walls of cartridge 110 with sufficient force and creating sufficient friction to keep the plunger rod 128 during transport and handling by the user. At the same time the friction between the plunger rod guide 603 and the cartridge 110 walls is small enough to be easily overcome by the user when pressing plunger rod at pad 129 and pushing the plunger rod against stopper 112 during the mixing, priming or injection stroke. The arrangement and shape of the wings or arms 607 shown in FIGS. 19b and 19c are only one example of what may be used and many other shapes and arrangements are possible that can achieve the same result.
[0156] FIGS. 20 shown alternative ways to insert the cartridge into the syringe housing.
[0157] In FIG. 20a the cartridge 110 is inserted into the syringe housing 127 axially at its proximal end and is held either at the cartridge proximal end in position by one or more snap fits 255 and/or by snap fits 259 at its distal end at the cartridge shoulder (113a) and/or cap (95).
[0158] In FIG. 20b the cartridge 110 is inserted into the syringe housing 127 radially through a slot 258 and is held in the syringe housing in position by one or more snap fits 256 and by a housing shoulder 257 at the proximal end of the syringe housing.
[0159] Note that in the above Figures the injection needle is sometimes shown replaced by nozzle which can be a screw fit, a luer slip or a luer lock, a slip tip, a catheter tip or an eccentric tip to enable the user to attach the injection needle or an intravenous infusion tube after removing the device from the sterile packaging. This applies to all embodiments where the delivery means can be a needle or any other means. If a catheter tip or an eccentric tip is supplied, it is advantageous to keep the cap and locking mechanism separate so that the cap can be removed to attach the needle or intravenous line before unlocking the cartridge.
[0160] It is also a feature of the present invention that if the syringe system is supplied in a sterile blister or sterile pack a needle or a nozzle cap is not essential.
[0161] Note that in the above Figures the cartridge may be replaced by a dual chamber cartridge for the reconstitution lyophilized pharmaceuticals or drugs or any other dry powders or the mixing of two pharmaceutical or drug solutions or formulations or any other solutions prior to injection. For mixing the lyophilized drug and the diluent or the two drug formulations the cartridge is pushed forward to perforate the septum allowing the air in the cartridge to exit through the needle when pushing the plunger rod to mix the drug solution. It this arrangement it may be an advantageous to have a two-position needle cap. For example, the cap may be rotated to release the cartridge lock and pulled to remove and remain in place protecting the needle until used. Alternatively in this embodiment it may be advantageous to keep the cap and lock separate so that the cartridge can be unlocked to mix the drug before the cap can be removed and the injection needle exposed.
[0162] Note that in some embodiments shown in the above Figures the syringe may be supplied to the user already in place or separately. In the Figures the cartridge is shown as supplied already in place or after the user has inserted the cartridge.
[0163] The cartridge may be inserted by the user axially from behind in which case the plunger rod may be attached to the syringe body by for instance a hinged or the plunger rod may be detached as a separate part, or the cartridge may be inserted radially from the side through a slot. If the cartridge is supplied to the user already in place in the syringe the combination product is terminally sterilized.
[0164] Note that the embodiments of the present invention shown in the Figures may be combined in any way.
