SINGLE-USE CASSETTE ASSEMBLY

Abstract

The invention relates to a single-use cassette assembly for use in a reusable solid dose formulation delivery actuator device. Such improvements permit delivery of at least one therapeutic or prophylactic compound, or a solid dose formulation including, for example, a vaccine comprising the same with improved safety and reliability. The invention further concerns an improved needle-free method for delivering at least one therapeutic compound or a formulation comprising the same.

Claims

1. A single use cassette assembly for use with a parenteral delivery actuator and configured to allow operative connection therewith, the cassette assembly comprising: a re-use prevention mechanism including at least: a cassette with one or more lockout clips having a first configuration, which permits use of the cassette with the actuator and a second configuration, which prevents re-use with the actuator and prevents reinsertion of the cassette into the actuator to an extent possible to enable actuation.

2. The single use cassette assembly of claim 1 wherein the first configuration is a non-extended state and the second configuration is a naturally biased extended state.

3. The single use cassette assembly of claim 1; wherein the re-use prevention mechanism comprises at least one lock-out clip.

4. The single use cassette assembly of claim 1, wherein the cassette assembly further comprises a cassette body for engaging the actuator device and a carriage housed within the cassette body, the carriage having a channel configured to releasably retain a solid dose formulation.

5. The single use cassette assembly of claim 4, wherein each lockout clip has a first end clamped to the cassette body and a second end comprising a hook, and wherein the cassette body comprises a hook retaining edge for engaging the hook in the second configuration.

6. (canceled)

7. The single use cassette assembly of claim 4 wherein the carriage and cassette body comprise aligned apertures in which the lockout clips sit.

8. The single use cassette assembly of claim 4, wherein the lockout clips remain in first a configuration or non-extended state until the cassette is actuated forcing the lockout clips to deflect outwardly to their second configuration or naturally biased extended state hooking the cassette body and preventing re-use of the cassette with the actuator.

9. (canceled)

10. The single use cassette assembly according to claim 4, wherein the cassette lockout clips comprise spring steel sheet-metal or other shape-memory material.

11. The single use cassette assembly according to claim 4, wherein the cassette assembly further comprises a cassette pin positioned rearwardly from the solid dose, and wherein the cassette pin is temporarily secured by one or more pin release clips preventing any forward motion being transferred to the solid dose prior to actuation of the actuator.

12. (canceled)

13. The single use cassette assembly according to claim 4, wherein the carriage body further defines at least one or more pin clip windows, the pin-release clips being configured to deflect into the pin clip windows to allow forward motion of the cassette pin within the carriage at the desired point during actuation.

14. The single use cassette assembly according to claim 4, wherein the carriage is releasably secured within the cassette body by one or more pre-release legs and wherein the pre-release legs are released when the cassette assembly is inserted into the actuator by a feature in the actuator mechanism.

15. The single use cassette assembly according to claim 4, wherein the carriage is adapted to be guided by rails within the cassette assembly and/or wherein the carriage comprises carriage jaws and a cassette opening cone.

10. The single use cassette assembly according to claim 4, wherein the cassette assembly further comprises a solid dose viewing window.

17. (canceled)

18. The single use cassette assembly according to claim 4, wherein the solid dose is a splinter or an implant and/or comprises a vaccine.

19-20. (canceled)

21. A kit comprising a solid dose needle-free delivery actuator and the single use cassette assembly according to claim 4.

22. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The various aspects of the invention will now be described, by way of example only, with reference to the following drawings.

[0032] FIG. 1 shows a cassette assembly in cross-section, according to an embodiment of invention in an unactuated state;

[0033] FIG. 2 shows the cassette assembly of FIG. 1 in the pre-actuated state, with the actuation spindle in alignment;

[0034] FIG. 3 shows the cassette assembly of FIG. 2 moved to an actuating position with the lockout clips activated and the carriage moved within the cassette body;

[0035] FIG. 4a shows the cassette in an actuated state;

[0036] FIG. 4b shows an isometric view of the same actuated cassette in FIG. 4a;

[0037] FIG. 4c shows the cassette of FIG. 4a housed relative to the actuator body immediately after actuation;

[0038] FIG. 5 shows the transitional release position of the used cassette from the actuator body with the lockout clips in a folded configuration to allow release of the cassette assembly from the actuator; and

[0039] FIG. 6 shows the cassette in an actuated state after it has been released from the skin and is ready for removal and the cassette lockout clips have exited the actuator housing and are preventing re-insertion and therefore re-actuation.

DETAILED DESCRIPTION

[0040] The cassette assembly of the invention (1) is typically used with and actuated by a parenteral needle-free solid dose delivery device of the type described in the applicant's earlier patent publications (as referred to herein above), hereafter referred to as an actuator.

[0041] The cassette is adapted to deliver a solid dose formulation containing a therapeutic compound, such as a vaccine, by pushing the solid dose into a human or animal body using the energy supplied by an actuator. In such use, cassette assemblies which house the solid dose formulation are preferred to be consumable, non-reusable cartridges. Patient safety is enhanced by the advantages the cassette assembly disclosed herein confers to the overall delivery mechanism.

[0042] FIG. 1 shows a cassette assembly (1), as provided in one embodiment of the invention, in a non-actuated state which houses a solid dose formulation (117).

[0043] Such a needle-free delivery device (shown partly in FIGS. 4c, 5 and 6) comprises housing components including a body (200). During use, the cassette assembly containing the solid dose is connected into the front section of the actuator body and the cassette and actuator are in operative communication with one another. The actuator houses a force generating means, such as a spring.

[0044] During use, the front section houses the connected cassette assembly (1) as per the invention, as described herein, including a solid dose formulation (117), and a means for transmitting the force provided from the force generating means, in order to push the solid dose formulation (117) from the cassette assembly (1) into the body via displacement of the cassette pin (105).

[0045] In the first unactuated mode, the cassette assembly (1) is connected to the front section of the actuator (not shown) and is axially orientated.

[0046] The cassette body (103) of the assembly houses a cassette carriage (107) which, in turn, houses a centrally positioned cassette pin (105) and a solid dose formulation (117). These components are initially fixed in position within the cassette body.

[0047] The carriage is held in position within the cassette body by pre-release legs (151) sitting within pre-release windows (150) in the cassette body. The carriage is releasably secured within the cassette body by pre-release legs. The carriage is held in place within the cassette body by the pre-release legs before actuation. These pre-release legs keep the carriage, pin, solid-dose assembly in place inside the cassette body in a fixed axial position until point of actuation and release/delivery is required.

[0048] The carriage includes two jaws (109) located in the front of the carriage (107). The solid dose formulation (117) is held by compression acting on its external surface. In particular, the lateral compressive forces of the jaws generate sufficient friction to retain the solid dose (117) in this position within the carriage (107) during storage and general movement or transport of the device, until the point of actuation and release/delivery is required.

[0049] Two or more lockout clips (111) are clamped onto an external surround of the cassette body (103) each clip comprises a hooking element. In their non-deflected, pre-actuation position the hooking element of the clip is releasably engaged onto an inner surface of the carriage (107) through an opening or window (113) in the cassette body (103). However, the natural shape of the clips is in the extended or deflected position, which itself allows a consistent holding force of the hooking element. Cassette lockout clips (111) are made, for example, from spring steel sheet metal.

[0050] The cassette pin (105) is positioned behind the solid dose formulation (117) abutting a rear-facing end thereof. The pin is initially held in place within the carriage (107) by a set of pin release clips (115). The pin release clips are latched onto corresponding groove or grooves in the pin during the assembly of the cassette (1).

[0051] In the pre-actuated mode, the pin release clips (115) cannot deflect/extend out as they are held and or constricted by the inner diameter size of the cassette body (103). The pin release clips are ‘V’ shaped to control the axial position of the cassette pin (105) inside the carriage (103). The secure pin ensures no unintentional forward motion is transferred to the solid dose relative to the carriage prior to intentional controlled actuation of the device.

[0052] The cassette pin and actuator are in operative communication through a spindle (not shown). The spindle tip (119) is adapted to push the cassette pin upon actuation which in turn pushes the solid dose formulation from the cassette assembly into the human or animal body.

[0053] In operation, once the cassette is inserted into the actuator it can be actuated by a user holding the device about its housing and pressing the device against the patient's skin. This causes the skin to be tensioned and the cassette to slide up inside the front section of the actuator. This sliding action is used to prime and ultimately cause the spring in the actuator to be compressed until the necessary drive force is reached and the full mechanism actuates.

[0054] When actuation of the device is fully initiated the spindle (119) pushes the carriage (107), cassette pin (105) and solid dose (117) forward. In examples the front end of the actuator may include a shape (not shown) to release the pre-release legs (151) of the carriage from the pre-release window (150) on the cassette body. As the carriage is accelerated forward, the carriage jaws (109) retaining the solid dose hit the opening cone of the cassette body (100) releasing the solid dose. At the same moment the pin release clips (115) reach the pin release windows (113) on the cassette body and are pushed into them allowing the cassette pin to move forward relative to the carriage, thus enabling it to push the solid dose into the skin. The carriage-pin-solid dose assembly may be guided by rails to prevent rotation of the mechanism. The timing of the release of the pin ensures that the solid dose is released from the carriage jaws before it is pushed forward by the cassette pin. The opened jaws allow for the pin to move forward with minimum friction. The solid dose penetrates the skin as the required acceleration and the required velocity is generated from the actuation mechanism of the device.

[0055] As shown in FIG. 3, during actuation the carriage moves forward within the cassette assembly releasing the hook of the lockout clips from the inner surface of the carriage. This allows the clips to freely deflect out and assume their naturally extended state. The clip hooks are at this point engaged with a hook retaining edge (123) on the cassette body (103).

[0056] Immediately after actuation the cassette is housed within the body of the actuator with the lockout clips in their naturally extended state as shown in FIG. 4c.

[0057] FIG. 5 shows how the lockout clips easily temporarily deflect inwards with minimum force to clear the opening diameter of the actuator in order to remove the cassette from the actuator immediately after its first actuation.

[0058] However, as shown in FIGS. 4a, 4b and 6 when the cassette is in the most forward position, the deflected lockout clips do not allow for the cassette to be actuated again, even when the cassette is pressed against the skin as they prevent the cassette body from sliding up inside the front section of the actuator, thus preventing the actuator mechanism from being primed and actuated.