Medical injection device with telescopically movable needle shield having a cleaning chamber for the needle
10518023 ยท 2019-12-31
Assignee
Inventors
- Ruben Archilla (Copenhagen, DK)
- Morten Soerensen (Ballerup, DK)
- Morten Revsgaard Frederiksen (Copenhagen, DK)
- Mattias Ingerslev (Copenhagen, DK)
Cpc classification
A61M5/326
HUMAN NECESSITIES
A61M2005/3267
HUMAN NECESSITIES
A61M5/2033
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M5/31583
HUMAN NECESSITIES
A61M5/31501
HUMAN NECESSITIES
A61M5/3202
HUMAN NECESSITIES
A61M2005/2474
HUMAN NECESSITIES
A61M5/3271
HUMAN NECESSITIES
International classification
A61M5/00
HUMAN NECESSITIES
A61M5/32
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
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:
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(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
(22)
(23) The needle cannula 30 is secured in a hub 40 which is movable from a first position depicted in
(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
(27)
(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
(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
(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
(34) The proximal part 33 of the needle cannula 30 is preferably maintained sterile in a polymeric bag 35.
(35)
(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
(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
(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.
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(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
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(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
(51) Internally the shield 110 is provided with an inwardly pointing rib 112 as best seen in
(52) Further as disclosed in
(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
(54) Once the hub 140 reaches its final proximal destination as disclosed in
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(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
(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
(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
(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
(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.
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(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
(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
(69) As seen in
(70) In the position disclosed in
(71) The transfer element 180 further abuts the distal end of the cartridge 160 as e.g. disclosed in
(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
(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
(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
(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.