Medical injection device with telescopically movable needle shield having a cleaning chamber for the needle

10518023 ยท 2019-12-31

Assignee

Inventors

Cpc classification

International classification

Abstract

The invention relates to a pre-filled injection device for apportioning set dose of a liquid drug. The housing of the pre-filled injection device internally supports a non-replaceable cartridge (160) having an hollow interior containing a liquid preservative containing drug and externally supporting a removable protective cap (150). The piston rod drive system of the injection device comprises a piston rod abutting a plunger provided inside the cartridge. A needle cannula (130) having a distal part with a distal tip and an opposite proximal part and a lumen there between is insertable into the cartridge. A telescopically movable (110) shield movable from an extended position covering at least the distal tip of the needle cannula to a retracted position exposing at least the distal tip of the needle cannula is further provided. The telescopically movable shield carries a cleaning chamber (120) able to contain a quantum of the liquid preservative containing drug for cleaning at least the distal tip of the needle cannula between subsequent injections. The quantum of the liquid preservative containing drug contained in the hollow interior of the cartridge is transferred to the cleaning chamber through the lumen of the needle cannula by moving the cartridge axially in relation to the plunger by use of a transfer assembly.

Claims

1. A pre-filled injection device for apportioning set dose of a liquid drug comprising: a housing distally supporting a removable protective cap rotatable mounted on the housing, and which housing proximally supports a piston rod drive system, a non-replaceable cartridge embedded in the housing of the pre-filled injection device and having an interior containing a liquid preservative containing drug, the cartridge having a movable plunger with a proximal surface abutting the piston rod drive system which comprises a piston rod, for moving the movable plunger in the distal direction wherein the piston rod is prevented from movement in the proximal direction by a one-way ratchet, a needle cannula having a distal part with a distal tip and an opposite proximal part and a lumen there between, a telescopically movable shield movable from an extended position covering at least the distal tip of the needle cannula to a retracted position exposing at least the distal tip of the needle cannula, and which telescopically movable shield carries a cleaning chamber for containing a cleaning solvent for cleaning at least the distal tip of the needle cannula between subsequent injections, wherein the cleaning chamber has a variable volume and comprises a movable piston operating inside the cleaning chamber, wherein the cleaning solvent inside the cleaning chamber when filled, is identical to the liquid preservative containing drug contained in the interior of the cartridge and wherein the liquid preservative containing drug is filled into the cleaning chamber through the lumen of the needle cannula by moving the movable plunger and the cartridge relatively to each other, and wherein a transfer assembly is provided for transferring rotation of the removable protective cap to an axial displacement of the cartridge in the proximal direction and wherein the plunger is proximally supported by the piston rod and prevented from moving in the proximal direction, wherein the transfer assembly comprises a transfer element engaging a hub which carries the needle cannula and wherein the transfer element and the hub are coupled by a threaded connection, wherein the transfer element moves proximally when rotated, such that the liquid preservative containing drug is forced from the cartridge and into the cleaning chamber as the transfer element moves the cartridge in the proximal direction and the plunger is prevented from movement in the proximal direction.

2. A pre-filled injection device according to claim 1, wherein the removable protective cap is provided with a structure for translating rotation of the removable protective cap to rotation of the shield.

3. A pre-filled injection device according to claim 2, wherein the shield is provided with a structure for translating rotation of the shield to a rotation of the hub.

4. A pre-filled injection device according to claim 3, wherein the hub when rotated screws proximally in the threaded connection.

5. A pre-filled injection device according to claim 3, wherein the hub is provided with a structure for translating rotation of the hub to a rotation of the transfer element.

6. A pre-filled injection device according to claim 5, wherein the transfer element is helically guided in the housing.

7. A pre-filled injection device according to claim 6, wherein the housing is provided with a protrusion engaging a track provided in the transfer element.

8. A pre-filled injection device according to claim 7, wherein the protrusion is provided in a tube structure forming part of the housing.

9. A pre-filled injection device according to claim 1, wherein the transfer element abuts the cartridge such that the cartridge follows the proximal movement of the transfer element.

10. A pre-filled injection device according to claim 1, wherein the cleaning chamber is formed between a distal septum and a piston being movable mounted in an outer part secured to the shield.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which:

(2) FIG. 1 shows a cut-open view of a first example of an injection device

(3) FIG. 2 shows a cut-open view of the injection device of FIG. 1 with the cleaning chamber filled.

(4) FIG. 3 shows a cut-open view of a second example of an injection device.

(5) FIG. 4-4A shows a cut-open view of the injection device of FIG. 3 with the cleaning chamber filled.

(6) FIG. 5-5A show a cross sectional view of an embodiment of the injection device in a stored condition.

(7) FIG. 6 show a perspective view of the engagement between the protective cap and the housing.

(8) FIG. 7 show a perspective view of injection device with the proximal part of the needle cannula inserted into the cartridge.

(9) FIG. 8 show a cross-sectional view of the injection device through the line Z-Z in FIG. 5A.

(10) FIG. 9 show a view as in FIG. 7 with the needle cannula and the cleaning chamber removed for visual purposes.

(11) FIG. 10 show an exploded view of the engagement between the transfer element and the hub.

(12) FIG. 11 show a perspective view of the engagement between the transfer element and the hub.

(13) FIG. 12 show a view of the engagement between the housing and the shield.

(14) FIG. 13-13A show a cross-sectional view of the injection device with the needle cannula inserted in the cartridge.

(15) FIG. 14 show a cut-open view of the engagement between the transfer element and the housing.

(16) FIG. 15 show a perspective view of the one way mechanism.

(17) FIG. 16-16A show cross-sectional views of the injection device with the cleaning chamber filled.

(18) FIG. 17 show a perspective view of FIG. 16A.

(19) The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.

DETAILED DESCRIPTION OF EMBODIMENT

(20) When in the following terms as upper and lower, right and left, horizontal and vertical, clockwise and counter clockwise or similar relative expressions are used, these only refer to the appended figures and not to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.

(21) In that context it may be convenient to define that the term distal end in the appended figures is meant to refer to the end of the injection device pointing towards the user during injection as indicated in FIG. 5, whereas the term proximal end is meant to refer to the opposite end usually carrying the dose dial button. Distal and proximal is meant to be along an axial orientation extending along the longitudinal axis of the injection device.

(22) FIG. 1 and FIG. 2 discloses an example of a pen-shaped injection device 1 with a housing 2 in which a shield 10 is slidable mounted as disclosed in WO 2015/062845. The slidable shield 10 carries a cleaning chamber 20 for cleaning the tip 32 of the needle cannula 30 between injections. The housing 2 of the injection device 1 further secures a cartridge 60 containing the liquid drug to be injected.

(23) The needle cannula 30 is secured in a hub 40 which is movable from a first position depicted in FIG. 1 to a second position depicted in FIG. 2. The needle cannula 30 has a distal part 31 with a distal tip 32 extending in the distal direction from the hub 40 and a proximal part 33 extending in the opposite proximal direction. A lumen 34 extends through the needle cannula 30 along the axial direction.

(24) The cleaning chamber 20 is essentially made up from two parts 21, 23 which are telescopically movable in relation to each other. The inner part 21 is distally provided with a piston 24 and the outer part 23 is permanently attached to the shield 10 e.g. by being moulded integral with the shield 20.

(25) In one example, the outer part 23 is a separate part permanently attached to the shield 10. When the outer part 23 is formed as a separate part it can be moulded from a different material (from the shield 10) e.g. a material optimized for being in contact with the cleaning solvent contained inside the cleaning chamber 20. As an alternative to being a separate part, the outer part 23 can be moulded together with shield 10 in a 2K moulding, e.g. in a 2K moulding with different materials.

(26) In FIG. 1 the inner part 21 is in its initial position abutting the distal septum 22 (via the piston 24) and the volume of the cleaning chamber 20 is thus rather small as it is formed as a carved-out part of the piston 24. In FIG. 2, the inner part 21 is slided axially in the proximal direction to increase the volume of the cleaning chamber 20.

(27) FIG. 1 discloses the injection device 1 in the storage condition. The proximal end 33 of the needle cannula 30 is located distally to the cartridge 60 and no flow has been established. When the user initiates first use of the injection device 1 a not-shown mechanism moves the hub 40 in the proximal direction into the position disclosed in FIG. 2. The inner part 21 is slidable relatively to the hub 40 but coupled to the hub 40 to follow the proximal movement of the hub 40. The inner part 21 is thus pulled proximally by the hub 40 and the volume of the cleaning chamber 20 is increased.

(28) The inner part 21 is distally constructed to carry a piston 24 which slides inside the outer part 21. Distally the cleaning chamber 20 is bordered by a distal septum 22 through which the distal part 32 of the needle cannula 30 penetrates during injection.

(29) As the inner part 21 together with the piston 24 slides axially in the proximal direction a vacuum is created inside the cleaning chamber 20. The vacuum is growing as the cleaning chamber 20 is increased in volume. The vacuum sucks liquid drug from the cartridge 60 and into the cleaning chamber 20 through the lumen 34 of the needle cannula 30 as the proximal part 33 of the needle cannula 30 is penetrated into the cartridge 60.

(30) In FIG. 2, the injection device 1 is ready to perform an injection. The hub 40 and the inner part 21 have moved proximally together and the hub 40 is now locked to the cartridge 60 by engaging means 41 securing the hub 40 axially. Further, the inner part 21 is locked to the outer part 23 via a locking groove 25 engaging the outer part 23 such that the inner part 21 and the outer part 23 moves axially together and relatively to the locked hub 40 whenever the shield 10 is moved.

(31) The result being that the proximal end 33 of the needle cannula 30 hereafter remains penetrated into the interior of the cartridge 60 and the cleaning chamber 20 hereafter has a constant volume which is filled with liquid drug. Multiple injections can hereafter be performed and the compression spring S1 urges the shield 10 in the distal direction such that the distal tip 32 of the needle cannula 30 is maintained inside the now filled cleaning chamber 20 between subsequent injections.

(32) A different embodiment is disclosed in FIG. 3 and in FIG. 4-4A wherein the same numeral numbers are used for the same elements. FIG. 4A is an enlarged view of the circled part of FIG. 4.

(33) The liquid drug is contained in the interior of the cartridge 60 which is proximally closed by a movable plunger 61 and distally sealed by a pierceable septum 62 to be pierced by the needle cannula 30. In FIG. 3 and FIG. 4 the proximal part 33 of the needle cannula 30 is located distal to the cartridge 60 such that liquid communication has not yet been established.

(34) The proximal part 33 of the needle cannula 30 is preferably maintained sterile in a polymeric bag 35.

(35) FIG. 3 discloses the injection device 1 in the storage condition wherein the distal part of the injection device 1 is covered by a protective cap 50. This cap 50 is proximally provided with an internal circumferential groove 51 which locks over a ridge 3 provided externally on the housing 2.

(36) Distally the cleaning chamber 20 is provided between an inner part 21 carrying a piston 24 and an outer part 23 secured to the shield 10. Distally the cleaning chamber 20 is bordered by a distal septum 22.

(37) When the user pulls off the cap 50 to initiate an injection as indicated by the arrow A in FIG. 4, the shield 10 is press fitted interior in the cap 50 such that the shield 10 follows the axial movement of the cap 50. A stop for the distal movement of the shield 10 can be provided.

(38) Once the cap 50 moves the shield 10 axially the cleaning chamber 20 is generated and a vacuum is automatically created in the cleaning chamber 20 such that liquid drug is sucked into the cleaning chamber 20 from the cartridge 60 once the hub 40 is moved proximally such that the proximal part 33 of the needle cannula 30 penetrates into the cartridge 60.

(39) The housing 2 can further be provided with a further stop 4 which stops the axial movement of the cap 50 in a pre-determined position preferably defining the length of the cleaning chamber 50.

(40) A further embodiment according to the invention is disclosed in the FIGS. 5 to 17. The same numbering is utilized for this embodiment, however with a 1 in front of the numerals.

(41) The distal part of the housing 102 supports a protective cap 150. Further embedded in the housing 102 is the cartridge 160. The cartridge 160 is proximally sealed by the movable plunger 161 and distally by a septum 162 to be penetrated by the proximal part 133 of the needle cannula 130.

(42) The proximal part of the housing 102 contains the piston drive system 170 which during injection drives the piston rod 171 forward to press the plunger 161 further into the interior of the cartridge 160 as is known from the prior art. In one example the piston rod 171 has a longitudinal thread 172 such that the piston rod 171 can be screwed forward by the piston rod drive system 170.

(43) Distally the distal tip 132 of the needle cannula 130 is covered by a telescopically movable shield 110.

(44) The telescopically movable shield 110 carries the cleaning chamber 120 formed between the outer part 123 and the slidable piston 124. Proximally the cleaning chamber 120 is bordered by a pierceable distal septum 122.

(45) FIG. 5-5A discloses the injection device 101 as it is stored and delivered to the user. The cleaning chamber 120 is sterilized and empty and the proximal part 133 of the needle cannula 130 is held in a position outside the septum 162 of the cartridge 160. In this position no liquid communication between the interior of the cartridge 160 and the lumen 134 of the needle cannula 130 has been established.

(46) In order to transfer liquid drug from the interior of the cartridge 160 and into the cleaning chamber 120 a transfer element 180 is provided which in response to the user rotating the protective cap 150 first applies the needle cannula 130 to the cartridge 160 and thereafter automatically transfers the correct amount of liquid drug from the cartridge 160 and into the cleaning chamber 120. This transfer element 180 is to be further explained.

(47) The connection between the housing 102 and the protective cap 150 is disclosed in FIG. 6. The housing 102 is on an exterior surface provided with a thread segment 105 which is engaged by an internal thread 152 such that the user is forced to rotate the protective cap 150 relatively to the housing 102 in order to remove the cap 150 prior to performing an injection.

(48) FIG. 7 depicts a perspective view of the distal end of the injection device 101 with the proximal part 131 of the needle cannula 130 penetrated through the septum 162 of the cartridge 160. This penetration is performed automatically when the user rotates the protective 150 relatively to the housing 102 in the threaded connection 105/152.

(49) For that purpose, the protective cap 150 is provided with an internally rib 153 engaging an outwardly pointing protrusion 111 located on the shield 110, such that whenever the user rotates the protective cap 150, this rib 153 translates rotation to the shield 110.

(50) This is further disclosed in FIG. 8 which is a view through the line Z-Z in FIG. 5A where it is seen that rotation of the protective cap 150 in an anti-clockwise direction as indicated by the arrow B also rotate the shield 110 in an anti-clockwise direction.

(51) Internally the shield 110 is provided with an inwardly pointing rib 112 as best seen in FIG. 9. This rib 112 abuts a flange 142 provided as an extension on the hub 140.

(52) Further as disclosed in FIG. 10, the hub 140 holding the needle cannula 130 (not shown in FIG. 10) is externally provided with a helical thread 143 engaging an internal thread 181 provided in the transfer element 180.

(53) As a result of the user rotating the protective cap 150, the needle hub 140 is thus screwed in the proximal direction in the threaded connection 181/143 and the proximal part 133 of the needle cannula 130 penetrates through the septum 162 and into the cartridge 160 as disclosed in FIG. 7.

(54) Once the hub 140 reaches its final proximal destination as disclosed in FIG. 7 and in FIG. 11 and the proximal part 133 of the needle cannula 130 has penetrated through the septum 162, the click-arm 182 on the transfer element 180 engages an opening 144 provided in the part of the hub 140 carrying the flange 142. This engagement secures that the hub 140 cannot rotate in the clock-wise direction (opposite B) as this would remove the proximal part 131 of the needle cannula 130 from the cartridge 160. In this way it is secured that once the proximal part 133 of the needle cannula 130 has been penetrated through the septum 162 and into the cartridge 160 it cannot be removed from this position.

(55) FIG. 11 further discloses a track 184 provided in an external surface of the transfer element 180, the use of which will be explained later. Further, the transfer element 180 has at least one outwardly pointing sealing rib 185, e.g. formed as a separate rubber sealing or moulded together with the transfer element 180, e.g. in a 2K moulding.

(56) FIG. 12 depicts the engagement between the shield 110 and the housing 101. When the user rotates the protective cap 150, the shield 110 rotates with the protective cap 150 due to the engagement with the protrusion 111 as explained. During this rotatable movement, the shield 110 also moves in the proximal direction in a helical movement since a helical groove 113 in the shield 110 is engaged by a guiding protrusion 106 provided in the housing 101. This helical groove 113 is also disclosed in e.g. FIG. 5. FIG. 12 further disclose two windows 114 in shield 110 making it possible for a user to inspect the content of the cartridge 160 before performing an injection.

(57) The shield 110 is urged in a distal direction by a compression spring S2 which is encompassed between the housing 102 and a support element 115 supporting the proximal end of the shield 110.

(58) The perspective view of FIG. 7 is further disclosed in FIGS. 13-13A in which liquid communication is now established such that liquid drug can flow from the interior of the cartridge 160, through the lumen 134 of the needle cannula 130 and into the user as the plunger 161 is moved forward inside the cartridge 160 by the piston rod 171 driven by the piston rod drive system 170. Further, the hub 140 is locked to the transfer element 180 by the engagement between the click-arm 182 and the opening 144 such that the needle cannula 160 cannot be pulled out from the cartridge 160.

(59) Once the proximal part 133 of the needle cannula 130 is properly inserted into the cartridge 160, the cleaning chamber 120 must be filled with liquid drug from the cartridge 60. This is done by further rotating the protective cap 150, the shield 110, the hub 140 and the transfer element 180 together.

(60) The hub 140 which secures the needle cannula 130 is proximally provided with a push surface 145 which is best seen in FIG. 5A and in FIG. 10. Once the hub 140 is rotated to its proximal position this push surface 145 at the end of its helical travel abuts a similar surface structure 183 provided on the transfer element 180. Thus in a length equal to the lengthwise extension of the engagement 145/183, the transfer assembly 180 rotates together with the hub 140.

(61) Further, a not-shown locking mechanism can be provided which ensures that the transfer element 180 can only rotate when the hub 140 has been moved proximally, this is to ensure that the filling of the cleaning chamber 120 can first be initiated when the proximal part 133 of the needle cannula 130 is fully inserted into the cartridge 160 to prevent that air is sucked into the cleaning chamber 120.

(62) As e.g. disclosed in FIG. 13, the housing 102 comprises an internal tube structure 190 in which the cartridge 160 is slidable positioned. This tube structure 190 is further depicted in a cut-open view in FIG. 14.

(63) This tube structure 190 can either be a separate part connected to the housing 102 or it can be moulded as an integral part of the housing 102. At the distal end the tube structure 190 has an inwardly pointing protrusion 191 which is best seen in the cut-open view in FIG. 14.

(64) This inwardly pointing protrusion 191 slides in the track 184 provided in the transfer assembly 180 such that when the transfer element 180 rotates together with the hub 140, the track 184 moves relatively to the protrusion 191.

(65) FIG. 13 and FIG. 13A illustrates the position after the proximal part 133 of the needle cannula 130 has penetrated through the septum 162 but before the transfer element 180 starts to rotate. In this position the cleaning chamber 120 remains empty.

(66) The transfer element 180 is provided with a sealing rib 185 which slides tightly against an inside surface of the shield 110. This sealing rib 185 makes it possible to maintain the needle cannula 130 in a sterile interior when the injection device 101 is delivered to the user. This is best seen in FIG. 5A which also discloses that the transfer element 180 making up the proximal part of the sterile interior is provided with a thin film 186 which in FIG. 13A is penetrated by the proximal part 133 of the needle cannula 130.

(67) This thin film 186 can in one example be moulded in a 2K moulding or it can be a separate foil, e.g. made from a suitable polymer or from paper.

(68) Further, as illustrated in FIG. 5A, the inside surface of the shield 110 is dislocated i.e. has a larger diameter in the distal region such that when the shield 110 is moved proximally as the shield 110 moves helically due to the track 113, the sealing rib 185 slides into an area with the larger diameter since the sterile interior is not needed anymore once the proximal part 133 of the needle cannula 130 has been pushed through the septum 162 and into the cartridge 160 as disclosed in FIGS. 13-13A.

(69) As seen in FIG. 10 and FIG. 14, the proximal sidewall of the track 84 comprises four different regions 187A, 187B, 187C, 187D which moves the transfer element 180 in the proximal direction in relation to the tube structure 190 as the transfer element 180 rotates and the protrusion 191 shifts between the regions 187 A, B, C, D.

(70) In the position disclosed in FIG. 13 and FIG. 13A the protrusion 191 rest against the first region 187A of the sidewall. When the transfer element 180 with the track 184 rotates, the protrusion 191 is lifted via the sloped region 187B up to the third region 187C. Since the protrusion 191 is a part of the housing 101 via the tube structure 180, the transfer assembly 180 is moved in the proximal direction relatively to the housing 102.

(71) The transfer element 180 further abuts the distal end of the cartridge 160 as e.g. disclosed in FIG. 13A such that when the transfer element 180 is forced proximally, the cartridge 160 is also forced to move proximally inside the tube structure 190 forming part of the housing 102.

(72) The piston rod 171 is in the piston rod drive system 170 secured against any backward movement as it is common in pre-filled injection devices. This can e.g. be made by providing the piston rod drive system with a one-way ratchet.

(73) This is disclosed in FIG. 15 which discloses a first drive part 175 secured in the housing 102 (see e.g. FIG. 13) and a second drive part 177 to be rotated during injection. The rotation of the second drive part 177 is preferably done by a spring such as a torsion spring. One of the first part 175 or the second part 177 is keyed to the piston rod 171 whereas the other part is threaded to the piston rod 171 such that when the first part 175 and the second part 177 is rotated relatively to each other the piston rod 171 is driven in the distal direction with or without rotating.

(74) In the disclosed embodiment, the first part 175 is provided with at least one ratchet arm 176 engaging a toothed outer surface 178 on the second part 177 such that the first part 175 and the second part 177 can only be rotated relatively to each other in one rotational direction thus being the direction that moves the piston rod 171 distally.

(75) As the piston rod 171 is prevented from backward movement so is the plunger 161 inside the cartridge 160 as the plunger 161 abuts the piston rod 171 e.g. via a piston rod foot distributing the force. Proximal movement of the cartridge 160 with the plunger 161 remaining in its position builds up a pressure in the interior of the cartridge 160.

(76) This pressure inside the cartridge 160 is build up as the protrusion 191 moves from the first region 187A to the third region 187C via the second region 187B, however, once the protrusion 191 reaches the fourth region 187D, the pressure is somewhat relieved since the fourth region 187D lies more proximal than the third region 187C. However, the fourth region 187D lies a little more distal than the first region 187A. The result being that the pressure increase going from the first region 187A to the third region 187C pumps out a quantum of drug from the cartridge 160 in order to start the piston 124 inside the cleaning chamber 120 to move where after the pressure build-up is reduced a little by going into the fourth region 187D.

(77) This situation wherein the protrusion 191 is in the fourth region 187D is disclosed in FIGS. 16-16A. As the transfer element 180 moves proximally a distance X, so does the cartridge 160 whereby the pressure build-up forces a predetermined amount of the liquid drug inside the cartridge 160 to flow through the lumen 134 of the needle cannula 130 and into the cleaning chamber 120.

(78) As the cleaning chamber 120 is filled, the piston 124 is moved proximally until it abut the stop surface 126 as best seen in FIG. 16A. This is further depicted in a perspective view in FIG. 17 in which the injection device 101 is ready to use.

(79) When an injection is to be performed, the user dials a dose using a dose setting button provided at a proximal end of the injection device 101. This rotation strains a torsion spring which is released to drive the piston rod 171 forward. Before releasing the torsion spring, the user removes the protective cap 150 and presses the distal end of the shield 110 against the skin such that the distal tip 132 of the needle cannula 130 penetrates through the distal septum 122 and into the skin of the user where after the torsion spring and thus the injection is released.

(80) When the end of the shield 110 is removed from the skin after the injection, the compression spring S2 urges the shield 110 back to its extended position such that the distal tip 132 of the needle cannula 130 is brought back into the cleaning chamber 120 wherein the distal tip of the needle cannula 130 is maintained between injections.

(81) Example of a Pharmaceutical Preservative Containing Liquid Drug:

(82) In one specific example, the liquid pharmaceutical preservative containing drug contained in the interior of the cartridge 160 and in the cleaning chamber 120 of the telescopic shield 110 could be NovoLog, which is manufactured and sold by the Danish company Novo Nordisk A/S.

(83) NovoLog is a sterile, aqueous, clear, and colourless solution that contains: insulin aspart 100 Units/mL glycerin 16 mg/mL phenol 1.50 mg/mL metacresol 1.72 mg/mL zinc 19.6 mcg/mL disodium hydrogen phosphate dehydrate 1.25 mg/mL sodium chloride 0.58 mg/mL water for injection

(84) NovoLog has a pH of 7.2-7.6 and Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

(85) The preservatives (phenol and metacresol) are simultaneously present both in the cartridge 160 and in the cleaning chamber 120 of the telescopic shield 110. Since the liquid inside the interior of the cartridge 160 and inside the cleaning chamber 120 are the same pharmaceutical preservative containing liquid drug, the exchange of liquid through the lumen 134 of the needle cannula 130 has no influence on the pharmaceutical preservative containing liquid drug to be injected as only the identical same pharmaceutical preservative containing liquid drug is present inside the cartridge 160 and in the cleaning chamber 120 of the telescopic shield 110 thus no contamination is possible.

(86) Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject matter defined in the following claims.