MEDICAMENT DELIVERY DEVICES
20210244886 · 2021-08-12
Inventors
Cpc classification
A61M5/345
HUMAN NECESSITIES
A61M5/3202
HUMAN NECESSITIES
A61M2005/2474
HUMAN NECESSITIES
A61M2005/247
HUMAN NECESSITIES
International classification
A61M5/24
HUMAN NECESSITIES
A61M5/32
HUMAN NECESSITIES
Abstract
A medicament delivery device comprising a cannula for delivery of medicament, a cartridge assembly comprising a cartridge having a medicament chamber and a collar adjacent a distal end opening of the chamber, a sealing element for sealing the distal end opening, and a coupling element for retaining the sealing element against a distal end of the cartridge. The device further comprises a hub assembly comprising a hub body and a sealing element release member. The device is switchable from a starting configuration in which the release member is spaced from the sealing element to an activated configuration in which the release member cooperates with the sealing element to connect the medicament chamber to the cannula. The coupling element comprises an annular clamping portion for applying a clamping force to the sealing element to seal the sealing element against the distal end of the cartridge, and a generally tubular engagement portion.
Claims
1. A medicament delivery device comprising a cannula for delivery of the medicament; a cartridge assembly comprising a cartridge having a medicament chamber and a collar adjacent a distal end opening of the chamber, a sealing element for sealing the distal end opening, and a coupling element for retaining the sealing element against a distal end of the cartridge; a hub assembly comprising a hub body and a sealing element release member; the device being switchable by relative movement between the hub assembly and the cartridge assembly from a starting configuration in which the release member is spaced from the sealing element to an activated configuration in which the release member cooperates with the sealing element to connect the medicament chamber to the cannula; wherein the coupling element comprises an annular clamping portion for applying a clamping force to the sealing element to seal the sealing element against the distal end of the cartridge, and a generally tubular engagement portion that extends distally from the clamping portion; the engagement portion being cooperable with the hub body to define a release member chamber, with an aseptic seal being disposed between the engagement portion and the hub body to seal at least a proximal end of the release member in the release member chamber when the device is in the starting configuration; and wherein the coupling element is attached to the cartridge by a crimp fitting.
2. A medicament delivery device according to claim 1, wherein the coupling element comprises a generally tubular skirt that extends proximally from the clamping portion to receive the collar.
3. A medicament delivery device according to claim 2, wherein the crimp fitting comprises the skirt.
4. A medicament delivery device according to claim 1 or claim 2, wherein the crimp fitting comprises a ring member disposed concentrically around at least the clamping portion of the coupling element and the collar.
5. A medicament delivery device according to any preceding claim, comprising latch means for latching the hub body and the coupling element in an activated position when the device is in the activated configuration.
6. A medicament delivery device according to claim 5, wherein the latch means comprises a latch formation provided on the hub body arranged for engagement with a corresponding latch formation provided on the coupling element.
7. A medicament delivery device according to any preceding claim, wherein the hub body comprises a proximally-projecting boss for the release member, the engagement portion being arranged to receive the boss and the aseptic seal being formed between the engagement portion and the boss at least when the assembly is in the starting configuration.
8. A medicament delivery device according to any preceding claim, comprising a seal member disposed between the hub body and the engagement portion of the coupling element to form the aseptic seal.
9. A medicament delivery device according to claim 8, wherein the seal member comprises an elastomeric cap mounted on the hub body, wherein the release member projects through the elastomeric cap.
10. A medicament delivery device according to claim 8, wherein the seal member comprises an O-ring.
11. A medicament delivery device according to any of claims 8 to 10, wherein the engagement portion comprises an inward projection for supporting the seal member.
12. A medicament delivery device according to any preceding claim, comprising a housing for receiving the cartridge assembly.
13. A medicament delivery device according to claim 12, wherein the hub assembly is moveable with respect to the housing and the cartridge assembly to switch the device from the starting configuration to the activated configuration.
14. A medicament delivery device according to claim 12, wherein the hub assembly is fixed with respect to the housing and the cartridge assembly is moveable with respect to the hub assembly to switch the device from the starting configuration to the activated configuration.
15. A medicament delivery device according to claim 14, wherein the hub body is integral with the housing.
16. A medicament delivery device according to any preceding claim, wherein the cannula is mounted in the hub body.
17. A medicament delivery device according to any preceding claim, wherein the release member comprises a tubular element arranged to pierce the sealing element upon switching of the assembly into the activated configuration.
18. A medicament delivery device according to claim 17, wherein the cannula comprises a distal part of a needle and the release member comprises a proximal part of the needle.
19. A medicament delivery device according to any preceding claim, further comprising a removable cap and a cannula chamber defined in part by the cap and arranged for receiving the cannula such that at least a distal end of the cannula is sealed in the cannula chamber when the cap is in place.
20. A medicament delivery device according to any preceding claim, comprising a clip formation arranged to allow engagement of the hub assembly with the coupling element during assembly of the packaging assembly and to prevent subsequent disengagement of the hub assembly from the coupling element.
21. A medicament delivery device according to claim 20, wherein the hub body comprises one or more inwardly-extending clips that cooperate with a collar of the coupling element to provide the clip formation.
22. A medicament delivery device according to any preceding claim, wherein the collar is disposed on a reduced-diameter neck of the cartridge.
23. A cartridge assembly for use in the delivery device of any preceding claim, the cartridge assembly comprising: a cartridge having a medicament chamber for containing a medicament and a collar adjacent a distal end opening of the chamber; a sealing element for sealing the distal end opening; and a coupling element for retaining the sealing element against a distal end of the cartridge, the coupling element comprising an annular clamping portion for applying a clamping force to the sealing element to seal the sealing element against the distal end of the cartridge, and a generally tubular engagement portion that extends distally from the clamping portion for engagement with a hub assembly of the device; wherein the coupling element is attached to the cartridge by a crimp fitting.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which like reference numerals are used for like features, and in which:
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
[0034] Throughout this specification, the term “distal” and related terms are used to refer to the end of the device that is closest to the injection site in use (i.e. to the right in
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035]
[0036] As shown in
[0037] The housing 12 of the device 101 defines an interior space 13 that accommodates a cartridge assembly 100. The cartridge assembly comprises a cartridge 102 having a medicament chamber 104 for containing a medicament. The cartridge 102 is generally tubular and has a reduced-diameter neck 106 at its distal end. As can be seen most clearly in
[0038] Referring particularly to
[0039] The coupling element 114 is attached to the cartridge 102 by a crimp fitting, which in this embodiment comprises a crimp ring 122, preferably formed of a ductile metal such as aluminium. During assembly, the tubular crimp ring 122 is mounted over the skirt 120 and the clamping portion 116 of the coupling element 114, and the ends of the ring 122 are bent inwardly around the proximal side of the collar 108 and the distal side of the clamping portion 116. With the crimp ring 122 in place, the clamping portion 116 of the coupling element 114 applies a clamping force to the septum 112 to seal the septum 112 against the distal end of the cartridge 102.
[0040] The coupling element 114 cooperates with a hub subassembly 124. The hub subassembly 124 comprises a hub body 126, a cannula in the form of a double-ended hypodermic needle 128, an elastomeric sealing cap 130 for forming a seal between the hub body 126 and the coupling element 114, and a cannula seal 132 for forming a seal between the hub body 126 and the needle 128.
[0041] The hub body 126 comprises a generally tubular proximal part 126a and a bell-shaped distal part 126b. The distal end of the hub body 126 has an end face 126c with a central aperture for receiving the needle 128. A tubular cap retaining part 126d surrounds the aperture and extends distally from the end face 126c. The needle 128 is fixed in the aperture by the cannula seal 132, which may for example be of a suitable elastomeric material. A distal end part 128a of the needle 128 projects away from the hub body 126.
[0042] A generally tubular boss 134 extends proximally from the end face 126c of the hub body 126, towards the proximal part 126a. The sealing cap 130 fits over the proximal end of the boss 134, and a proximal end part 128b of the needle 128 extends through the cap 130 to project into a release member chamber 136 defined by the septum 112, the tubular throat 118 of the coupling element 114 and the elastomeric cap 130 of the hub subassembly 124. The sealing cap 130 provides a seal member that forms a seal against the inner wall of the throat 118 of the coupling element 114, and is shaped to locate with an inward projection in the form of an annular ridge 138 formed on the inner wall of the throat 118.
[0043] The chamber 136 provides an aseptically sealed compartment for the proximal end part 128b of the needle 128. Thus, provided the cartridge assembly 100 and the hub subassembly 124 are assembled in sterile conditions, the proximal end part 128b of the needle 128 remains sterile until the device 101 is activated, as will be described below.
[0044] Distal movement of the hub subassembly 124 away from the coupling element 114 is prevented by a clip formation. As can be seen most clearly in
[0045] A cap sleeve member 140 is fitted to the distal side of the hub subassembly 124. The cap sleeve member 140 has a distally-extending bore 142 that defines, in part, a cap chamber 144 or cannula chamber for receiving the distal end part 128a of the needle 128. The cap retaining part 126d of the hub body 126 engages with an interference fit in a proximal end of the bore 142, to form a seal between the cap sleeve member 140 and the hub body 126. In an alternative arrangement (not shown), an O-ring seal is provided between the cap sleeve member 140 and the cap retaining part 126d of the hub body 126.
[0046] A small-diameter bore 146 extends proximally from the distal end of the cap sleeve member 140 to connect with the distally-extending bore 142. The small-diameter bore 146 is plugged with a cylindrical closure 148 comprising an air-permeable sterile barrier material, such as are available under the registered trade marks Tyvek (DuPont, Del., USA) and Vyon (Porvair PLC., Norfolk, UK). The closure 148 allows air to flow into or out of the cap chamber 144 and the release member chamber 136 (through the flow path provided by the cannula 128) to equalise the pressure in the chambers 136, 144. This eliminates pressure gradients across the seals between the septum 112 and the coupling element 114, between the coupling element 114 and the hub body 126, and between the hub body 126 and the cap sleeve member 140, reducing the risk of failure of these seals. The sterile barrier properties of the material of the closure 148 prevent microbial contamination of the cap chamber 144. In some cases (not illustrated), where equalisation of pressure is not required, the small-diameter bore 146 may be omitted so that the cap chamber 144 is closed and sealed by the distal end of the cap sleeve member 140.
[0047] The cap chamber 144 therefore provides an aseptically sealed compartment for the distal end part 128a of the needle 128. Provided the cap sleeve member 140 is engaged with the hub subassembly 124 in sterile conditions, the distal end part 128a of the needle 128 remains sterile until the device 101 is activated, as will be described further below.
[0048]
[0049] Each rib 150 is extended proximally to form a blocking member or blocking finger 150a. Each blocking finger 150a is received in a corresponding aperture 152 in the distal part 126b of the hub body 126.
[0050] Referring back to
[0051] Each rib 150 is also extended distally to form a clip formation 150c. The clip formations 150c are separated from the distal end region of the cap sleeve member 140 by slots 150d, so that the clip formations 150c are flexible. The clip formations 150c are used to couple the cap sleeve member 140 to the outer cap 18 of the device 101.
[0052] The cartridge assembly 100, the hub subassembly 124 and the cap sleeve member 140 together define a packaging assembly that can be pre-assembled in the starting configuration in a sterile environment. By virtue of the chambers 136, 144 and the seals, all of the components of the packaging assembly that will come into contact with the medicament in use, as well as the medicament in the medicament chamber 104 and the distal end part 128a of the needle 128 (which passes into the injection site) subsequently remain sterile.
[0053] One convenient way of pre-assembling the packaging assembly comprises first attaching the septum 112, the crimp ring 122, the coupling element 114 and the cap sleeve member 140 to the hub subassembly 124 and sterilising these components to from a sterile cannula module. The cannula module can then be secured to the distal end of the cartridge 102 by crimping the crimp ring 122.
[0054] The packaging assembly as a whole can then be installed in the delivery device 101. Advantageously, the cap sleeve member 140, the hub body 126 and the coupling element 114 all have smaller diameters than the diameter of the cartridge 102 so that the packaging assembly can be inserted into a device housing from the proximal end of the housing.
[0055] The device 101 can therefore be assembled by inserting the packaging assembly (i.e. the cartridge assembly 100 and the attached hub subassembly 124) through the proximal end opening of the interior space 234 of the housing 202 and pushing the assembly distally until the clip formations 150c of the cap sleeve member 140 engage in corresponding slots 20 provided in the distal end face of the outer cap 18. In the illustrated embodiment, the outer cap 18 is engaged with the housing 12 before the packaging assembly is inserted, but equivalently the packaging assembly could be inserted to the housing 12 and held in place while the outer cap 18 is subsequently attached, or the outer cap 18 could be attached to the cap sleeve member 140 before insertion of the packaging assembly into the device 101 from its distal end. In each case, the presence of the blocking formations 150a prevent the hub assembly 124 and the cartridge assembly 100 moving towards one another during the insertion process, keeping the components in the starting configuration irrespective of any linear forces applied during handling.
[0056] The proximal end fitting 14 clips into the proximal end of the housing 202 to retain the cartridge assembly 100 in the housing 12. The proximal end fitting 14 also provides a guide bore 22 for an elongate plunger rod 24 of the plunger 16. A distal tip 26 of the plunger rod 24 is formed to engage with a corresponding recess 111 in the proximal side of the bung 110.
[0057] To prepare the device 101 for use, the outer cap 208 can be removed from the housing 202, as shown in
[0058] To operate the device 101, the plunger 16 is pushed distally with respect to the housing 12. The force initially applied to the cartridge assembly 100, via the plunger rod 24 and the bung 110, causes the cartridge assembly 100 (i.e. the cartridge 102, the septum 112 and the coupling element 114) to move distally with respect to the hub subassembly 124, moving the throat 118 of the coupling element 114 into the distal part 126b of the hub body 126 as shown in
[0059] The elastomeric sealing cap 130 disengages from the ridge 138, and the proximal end part 128b of the needle 128 pierces the septum 112 to connect the needle 128 to the medicament chamber 104. The device 101 is now in an activated state in which a flow path from the medicament chamber 104 to the distal end of the needle 128 has been established.
[0060] Delivery of the medicament through the needle 128 can then take place by further displacement of the plunger 16 in the distal direction.
[0061]
[0062] In the
[0063] Also, instead of an elastomeric sealing cap, in this embodiment an elastomeric O-ring seal member 230 is used to provide the aseptic seal between the boss 134 of the hub body 126 and the throat 218 of the coupling element 214. The O-ring seal 230 is kept in place by the ridge 238 on the interior wall of the throat 218. It will be appreciated that other arrangements are possible and that any suitable means for forming an aseptic seal between the coupling element 214 and the hub subassembly could be provided to seal the proximal part 128b of the needle 128 in the chamber 136.
[0064]
[0065] In this case, the cap sleeve member 340 is formed integrally with the outer cap 38, as shown in
[0066] In this embodiment, the coupling element 314 lacks a proximally-extending skirt. Instead, the coupling element 314 consists of the ring-shaped annular clamping portion 316 that bears against the septum 112 and the distally-extending tubular throat 318, and the crimp ring 122 extends over the neck 108 of the cartridge 102, the septum 112 and the clamping portion 316 to retain the coupling element 314 on the distal end of the cartridge 102.
[0067] The tubular throat 318 of the coupling element 314 comprises a second collar 318c disposed on the outside wall of the throat 318. The second collar 318c is at an intermediate position between the clamping portion 316 and the collar 318b at the distal end of the throat 318.
[0068] In use of the device 301, the outer cap 38 can be removed to uncover the distal end part 128a of the needle 128, as shown in
[0069]
[0070] In this case, the skirt 420 of the coupling element 414 acts as the crimp ring, as described above with reference to
[0071] In this embodiment, the proximally-extending boss 434 includes a projection 435 that has a ramped proximal side and a distal side that is perpendicular to the axis of the boss 434. When the device 401 switches from the starting configuration shown in
[0072] In the
[0073] In this embodiment, the blocking formations comprise a plurality of radial ribs 48d, one of which can be seen in
[0074]
[0075] Although
[0076] For example,
[0077]
[0078]
[0079] In the examples of
[0080] Further variations and modifications may be contemplated. For example, in the illustrated examples, the cannula is a double-ended needle, and the proximal end part of the needle acts as a piercing member for the septum. However, a single-ended needle could be provided for delivery of the medicament, with a separate piercing member being formed integrally with the hub body or as a separate component. It is also conceivable that, instead of a septum, the distal end of the cartridge could be sealed by a valve, rupturable membrane or other sealing device. In such cases the sealing element may be released by a suitable release member, which need not be a piercing member but could instead be arranged to open a valve, rupture a membrane and so on.
[0081] The cannula need not be a needle, but could instead be a flexible cannula or other suitable infusion or injection device. The cannula need not be mounted directly in the hub body but could instead be connected to the hub body by a flexible tube or the like.
[0082] It will also be appreciated that the blocking formations need not extend through apertures in the hub body. The present invention extends to any arrangement in which a blocking formation of the cap cooperates with the cartridge assembly to maintain a clearance between the sealing element release member and the sealing element while the cap is in place.
[0083] Further modifications and variations not explicitly described above are also possible without departing from the scope of the invention as defined in the appended claims.