US-20260124396-A1 - IMPROVEMENTS IN NEEDLE-FREE DELIVERY

US20260124396A1US 20260124396 A1US20260124396 A1US 20260124396A1US-20260124396-A1

Abstract

The invention concerns improvements in needle-free devices for delivery of therapeutic and/or prophylactic agents, such as solid dose drugs, including vaccines. The needle-free device disclosed herein comprises novel structural arrangements and modes of actuation and operation, resulting in enhanced functionality and benefits to the user and/or patient.

Inventors

Owen RYAN
Pascal Launois
David Grant

Assignees

Avaxmed Limited

Dates

Publication Date: 20260507
Application Date: 20251229
Priority Date: 20191218

Claims (10)

1 . A needle-free device for delivery of a therapeutic and/or prophylactic agent comprising a housing including: a rear-end section including a force generator for pushing a solid drug comprising a therapeutic and/or prophylactic agent from said device; a front-end section for receipt of a cassette comprising the drug, the front-end section further comprising a front piston slidably mounted therein and in contact with the cassette, a reset spring arranged to exert a reaction force on the front piston and an internal structural constraint for retaining the cassette within the front-end section; and a cassette release and automatic ejection mechanism, in which a first casing enclosing the front-end section is axially rotatable relative to a second casing enclosing the rear-end section and twisting the casings relative to one another releases the internal structural constraint, thereby enabling the front piston to move forward under the force of the spring and cause automatic ejection of the cassette from the device.
2 . The device of claim 1 , wherein the first casing is axially rotatable relative to a second casing by approximately 90 degrees.
3 . The device of claim 1 , wherein the first front casing comprises a first release indicator (I) at a distal end thereof and the second rear casing comprises a second release indicator (II) at a proximal end thereof, such that axial rotation of the first casing relative to the second casing, moves the first release indicator I in a rotational direction towards release indicator II until the two release indicators I and II are in alignment and a dead stop is reached.
4 . The device of claim 3 , wherein the first casing comprises a directional indicator indicating the rotational direction for the alignment of the release indicators.
5 . The device of claim 1 , wherein the internal structural constraint is defined by at least a cassette bayonet peg and bayonet connecting ring in the front-end section of the device, configured to retain a cassette bayonet peg.
6 . The device of claim 5 , wherein the cassette release and automatic ejection mechanism further comprises a twist release ring and a release finger permitted to rotate axially in a dedicated track within the bayonet connecting ring in the front-end section.
7 . The device of claim 6 , wherein the release finger feature is in lateral contact with the cassette bayonet peg when a cassette is connected to the device and twisting the casings relative to one another rotates the twist release ring causing the release finger to engage the cassette via the cassette bayonet peg in rotation until the peg reaches a bayonet opening in the bayonet connecting ring enabling the force acting on the front piston to move it forward and eject the cassette from the device.
8 . The device of claim 1 , wherein the cassette release and automatic ejection mechanism further comprises an internal torsion spring configured to automatically return first casing enclosing the front-end to its original position.
9 . The device of claim 1 , in combination with a cassette for use with the device, the cassette housing a tablet, microtablet, splinter or solid dose comprising at least one therapeutic and/or prophylactic agent.
10 . The device of claim 9 , wherein the at least one therapeutic and/or prophylactic agent comprises a solid dose vaccine or solid dose immunological agent for the prevention or therapy of disease.

Description

RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 17/787,079, filed Jun. 17, 2022, which is a national phase application filed under 35 USC § 371 of PCT Application No. PCT/GB2020/053140 with an International filing date of Dec. 8, 2020, which claims priority of GB Patent Application 1918706.1 filed Dec. 18, 2019. Each of these applications is herein incorporated by reference in its entirety for all purposes. FIELD OF THE INVENTION This disclosure relates to improvements in a needle-free device for delivery of therapeutic and/or prophylactic agents, such as solid dose drugs, including vaccines. In particular, the needle-free device disclosed herein comprises novel structural arrangements and modes of actuation and operation, resulting in enhanced functionality and benefits to the user and/or patient. More particularly, the disclosure and invention herein relates to a new needle-free device for delivery of solid dose therapeutic and/or prophylactic agents, the device having a re-setting mechanism with improved reliability, permitting delivery of at least one therapeutic compound, such as a vaccine (or a formulation comprising the same) with improved safety and reliability. There is further disclosed a needle-free device for delivery of therapeutic and/or prophylactic agents, such as solid drugs, including vaccines, comprising a cassette releasing mechanism, further enhancing the safety and user experience when undertaking delivery of a therapeutic or prophylactic agent. The invention further concerns use of and methods relating to the needle-free delivery. BACKGROUND TO THE INVENTION A common route of administration of therapeutic or prophylactic agents is via parenteral delivery of a liquid formulation using needles and syringes. Parenteral delivery is used for therapeutic or prophylactic agents that are usually poorly absorbed by other routes and/or require rapid delivery. Parenteral delivery is also one of the more efficient routes for delivery compared to other standard delivery routes such as oral or pulmonary delivery. Among the disadvantages with parenteral delivery via a needle is the associated discomfort and pain for the patient and the health risk caused by used sharps. A large proportion of therapeutic or prophylactic agents are poorly soluble, often resulting in the production of sub-optimal formulations. In addition, they are typically less stable in aqueous form than in a solid dose form Potentially, drugs may be administered by accelerating powders to a velocity at which they can penetrate the outer layers of the skin. Such systems typically require a velocity of several hundred metres per second in order to penetrate human tissue. Other systems use solid rods or splinters of a therapeutic compound that can be pushed at a relatively low velocity into the skin without the requirement for a needle. The present applicants have successfully developed their own needle-free solid-dose delivery technology used as a means for introducing solid dose therapeutics, including proteins and vaccines. The development of the technology is described in at least International applications WO2003/023773, WO2004/014468, WO 2006/082439, WO 2006/082439 and WO2017/068351. The originating methods include delivering compounds or formulations by penetrating the skin with a pioneer projectile and introducing behind the projectile, the therapeutic of interest in a liquid, semiliquid or solid dose form. However, devices also permit solid dose delivery without the need for pioneer projectiles. These devices, suitable for needle-free delivery, are described by the present applicants at length and in a number of varying iterations and embodiments, for example, U.S. Pat. No. 8,574,188 and other disclosures. A needle-free device of this general type includes a disposable single-use component (also herein referred to as a cassette) and an actuator which is re-usable. The generic mechanism devised by the present applicants, by which the device and cassette operate, is described briefly herein but can be found in detail within the above international patent publication references. The disposable cassette comprises a central aperture in which an ejector or drive pin is mounted behind a drug package or injectate, which comprises a therapeutic agent and/or formulation. The disposable component, housing the drug package can be loaded into the actuator by positioning it e.g. by screwing it into the inner of the housing end of the actuator device. The front-end of the housing is in operative communication with the cassette, such that when assembled therewith and the device is operated, an actuation mechanism of the device generates a force sufficient to push the drug package from the cassette. Actuation may initially trigger with a push button or by pushing the disposable cassette (already loaded into the actuator device) against the skin. Under the force of a spring in the rear-end of the dev