Improvement of needleless delivery devices

Abstract

The present invention relates to improvements in needle-free devices for the delivery of therapeutic and / or prophylactic agents, such as solid-dose drugs including vaccines. The needle-free devices disclosed herein include novel structural arrangements and modes of operation and operation, thereby bringing enhanced functionality and benefits to users and / or patients.

Description

Technology Field

[0001] The present invention relates to improvements in a needleless device for delivering therapeutic and / or prophylactic agents, such as solid-dose drugs including vaccines. In particular, the needleless device disclosed herein includes a novel structural arrangement and modes of operation and operation to provide enhanced functionality and benefits to the user and / or patient. Background Technology

[0002] More specifically, the disclosure and invention of the present invention relate to a novel needleless device for the delivery of a solid-dose therapeutic and / or prophylactic agent, said device having a resetting mechanism with improved reliability that allows the delivery of at least one therapeutic compound as follows. It is provided as a vaccine (or a formulation containing the same) with improved safety and reliability.

[0003] A needleless device for delivering therapeutic and / or prophylactic agents, such as solid drugs including vaccines, is further disclosed, comprising a cassette release mechanism that further enhances safety and user experience when initiating the delivery of the therapeutic or prophylactic agent.

[0004] The present invention also relates to the use and method of a needleless delivery device. The problem to be solved

[0005] The common route of administration for therapeutic or prophylactic agents is the parenteral delivery of liquid formulations using needles and syringes. Parenteral delivery is generally used for therapeutic or prophylactic agents that are not well absorbed via other routes 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.

[0006] One of the disadvantages of parenteral delivery via needle is patient discomfort and pain, as well as health risks caused by the needle used.

[0007] Many therapeutic or prophylactic agents do not dissolve well, often resulting in suboptimal formulations. Additionally, they are generally less stable in aqueous forms than in solid dosage forms.

[0008] Potentially, drugs can be administered by accelerating powders to a speed capable of penetrating the outer layers of the skin. Such systems typically require speeds of hundreds of meters per second to penetrate human tissue. Other systems use solid rods or fragments of therapeutic compounds that can be pushed into the skin at relatively low speeds without needles.

[0009] The applicant has successfully developed a self-needleless solid-dose delivery technology used as a means for introducing solid-dose therapeutic agents, including proteins and vaccines. The development of this technology is described in at least international applications WO2003 / 023773, WO2004 / 014468, WO 2006 / 082439, WO 2006 / 082439 and WO2017 / 068351.

[0010] The original method involves delivering a compound or formulation by penetrating the skin with a pioneer projectile and introducing the therapeutic agent of interest in the form of a liquid, semi-liquid, or solid dose behind the projectile. However, the device allows for solid dose delivery without a pioneer projectile.

[0011] Such devices suitable for needleless delivery have been described at length by the applicant for various repetitions and embodiments, such as in US 8,574,188 and other disclosures.

[0012] The above general type of needleless device includes a disposable component (also referred to herein as a cassette) and a reusable actuator. The general mechanism devised by the applicant for the operation of the device and the cassette is briefly described herein, but can be found in detail in the aforementioned international patent references.

[0013] It includes a central hole in which an ejector or driving pin is mounted behind a drug package or injection solution containing a therapeutic agent and / or a formulation. A disposable component that accommodates the drug package can be loaded into the actuator by positioning it, for example, by tightening a screw inside the housing end of the actuator device.

[0014] The front end of the housing communicates with the cassette, is assembled together with the housing, and when the device is operated, the device's operating mechanism generates sufficient force to push the drug package out of the cassette.

[0015] Operation can be initiated by initially using a push button or by pushing a disposable cassette (already loaded in the actuator device) against the skin. Under the force of a spring at the rear end of the device, a striker (e.g., a hammer or spindle) moves along a guide within the housing and comes into contact with a pin. The pin (the driving pin in this disclosure) comprises a flat head and an elongated body and is positioned so that, upon contact, the drug package is pushed out along the central opening and from the cassette jaw. The generated energy is sufficient for the drug package to penetrate the skin. The pin continues to push the drug package into the patient to the required depth. This depth is partially determined by the length of the package and the degree of push-in by the pin.

[0016] Then, the applicant's device enables the skin to be penetrated by the drug package even during low-speed administration. Low speed is generally defined in this context as less than 100 m / s, but preferably less than 10 m / s. Because the drug is pushed at a lower speed than when injected at a high speed, it is possible to ensure that the dose is always delivered to the correct (same) depth under the skin. This means that the system can be used on different skin types and skin locations, and the dose is still delivered to the same depth. However, some problems remain with needle-free delivery of solid-dose drug therapy.

[0017] In a user-operated delivery device, it is desirable that reusable components, namely actuator devices, be easily and reliably reset after operation. Accordingly, in one aspect, the present invention stems from the desire to improve the reliability of needle-free drug delivery devices.

[0018] In addition, a means of removing the disposable cassette from the device after operation is important, and to improve the comfort and compliance of the operator, it is desirable to minimize contact with the recently injected end, even though there is no risk of needle stick. Accordingly, the present invention arises from the need to provide a needleless drug device for the delivery of therapeutic and / or prophylactic agents and / or a method of operating the same, which facilitates operator use and / or self-use.

[0019] The invention disclosed herein includes a needleless device for delivering at least one therapeutic agent and / or prophylactic agent comprising a housing having the following:

[0020] Rear end including a force generator and a rear piston;

[0021] A front end for receiving a cassette containing a solid therapeutic agent and / or prophylactic agent for delivery, said housing comprising a front piston having a central hole and defining an axis, said front piston being slidably mounted within the front end;

[0022] A spindle positioned between a front end and a rear end, operably communicating a rear piston with the front end, having a spindle tip, and configured to be laterally movable between a central hole and an axially aligned position and an axially offset position;

[0023] Reset spring seat;

[0024] A reset spring located between the reset spring seat and the front piston; and

[0025] A spindle retaining element structurally and functionally configured to exclusively hold the spindle in an axially offset position.

[0026] Safety and reliability related to the operation of the device are critical to ensuring the accurate delivery of the dose and the medicinal or preventive effect. The applicant has determined that the device may fail to reset and, in such cases, further use of the device by the patient / user may be prevented. means of solving the problem

[0027] The present invention provides a new solution to this problem. The reconfiguration of the mechanism and the inclusion of the new functional combination disclosed herein prevent the risk of failure of the reset mechanism and allow the patient or clinician to reuse the delivery device with each new therapeutic and / or prophylactic cassette.

[0028] The transmission device disclosed herein enables the spindle to be reliably released from its central axis and, crucially, is successfully maintained at an aligned or offset position rather than the axis when the forward piston is in the foremost position, i.e., when the cassette is not attached.

[0029] First, the reset spring located between the reset spring seat and the front piston allows the piston to be in the foremost position when the cassette is not attached, so that the spindle tip can be positioned at a radially outward position offset from the center axis.

[0030] Second, although the previous device had the function of returning the spindle to an offset position, this arrangement nevertheless exhibited reset failures as described above. The cause of the reset failures was not understood or its characteristics were not identified until the applicant conducted an investigation into the device structure and further development. Without being bound by theory, it was found that a possible cause of the reset failures lay in the implicit use of existing functions (already present in the device) for multiple functions. In other words, these were existing functions that provided additional functions beyond the basic mechanical role in device operation, but which could be suboptimal. A different solution was needed to prevent reset failures and improve reliability.

[0031] Usefully, the applicant discovered that a new configuration of the device of the present invention, including the introduction of a new individual element that is mechanically independent (i.e., not already present or essential for use in the primary operation of the device), can avoid reset failure. A mechanically independent spindle retaining element functioning alone to hold the spindle in an offset position was found to do so successfully without exception, thus providing an improvement over the device of the prior art. Usefully, a combination of the new configuration and features, including the independent structural features of the retaining element, provides sufficient additional force necessary to hold the spindle tip in a lateral offset position, so that the spindle does not move unintentionally. Through thorough testing, it was found that the operation of the device of the present invention successfully avoids reset failure events.

[0032] In some embodiments where the spindle tip is in an offset or axially misaligned position, the tip is adjacent to or held relative to the front piston. Particularly in the axially aligned position, the tip of the spindle is aligned with the central bore axis of the front piston while in contact with the rear of the front piston. For example, the surface facing the rear of the front piston temporarily contacts the rear of the piston (until the device is reloaded with a new cassette, primed, and operated). Thus, this surface can releaseably hold the spindle in the axially misaligned position before and after operation.

[0033] In an embodiment, the spindle retaining element retains the spindle tip with an axial offset by an attractive force laterally spaced from the central axis of the hole.

[0034] The force generator may include a compression or actuation spring.

[0035] In a preferred embodiment, the reset spring and the actuation spring are not positioned in series. The mechanism of the prior art uses a reset spring positioned in series with the actuation spring to provide the force required for the reset, thereby keeping the spindle in permanent contact with the rear piston and maintaining the front piston in the foremost position so that the spindle separates from the center hole of the front piston. However, this is undesirable as it may compromise the length of the device. A target speed of 6 m / s is required for transmission, and a minimum acceleration distance is required for this. Since some of the energy transmitted by the actuation spring is absorbed by the reset spring, an additional acceleration distance is required to compensate for this energy absorption, thereby increasing the overall length of the device. Therefore, in a preferred embodiment, the reset spring and the actuation spring are provided in a parallel arrangement. This arrangement involves the front piston moving to a position where the spindle tip moves freely without engaging with the center hole of the front piston, so that the spindle tip reaches the trigger point but a larger acceleration distance is not required. Advantageously, this allows for a shorter and therefore more compact device.

[0036] Means in which displacement is achieved, for example, by the use of partially lateral forces and / or radial attraction, can be implemented by a number of different embodiments. Accordingly, the spindle retaining element can be located adjacent to the spindle tip.

[0037] In one embodiment, the attractive element is a magnetic ring, and at least a portion of the spindle or spindle tip comprises metal. In a preferred embodiment, the ring is a unipolar radial magnetic ring. The ring may be located inside the rear end of a forward piston that can be opened. In this embodiment, the magnetic field generated by the ring attracts the metal spindle tip. For example, in the reset step, the forward piston moves forward due to a reaction force applied by the reset spring, and the spindle and spindle tip are separated from the central hole of the forward piston and are pulled by a magnetic attraction toward the magnetic ring, which is temporarily fixed in an axially offset position.

[0038] In another embodiment, the spindle retaining element is configured to deflect the position of the spindle. The spindle retaining element may include a secondary coil housed within the coil of the reset spring. In particular, one end of the reset spring may be wound in a spiral shape. The interior of the coil may have an inner diameter slightly larger than the diameter of the tip of the spindle. However, the final coil formed by the spiral is offset from the central axis so that the end of the spindle is displaced from the central axis during reset.

[0039] In some embodiments, the spindle retaining element has a fixed geometry and includes a spring wire attached to the front piston. The anchoring geometry includes a double-pitch coil that serves to retain the tip of the spindle at a minimum distance from the central axis. The fixed geometry is configured in a profile to temporarily pull the spindle or disalign it while resetting it to a position offset from the hole of the front piston.

[0040] In some embodiments, the rear piston is adjacent to the spindle by a rotary joint. In some examples, the rear piston may include a female connection or socket to accommodate a corresponding male connection located at the rear end of the spindle. The male connection of the spindle may include a ball for improved and reliable rotational movement with the rear piston. A rotatable connection between the rear piston and the spindle, such as a ball-socket joint, can help increase the movement of the spindle tip placement at the front end of the spindle. In particular, the connection allows the spindle to rotate laterally with minimal friction, improving the ability of the spindle to reset deflected by the displacement mechanism discussed. For example, the displacement of the spindle tip can be more precise and consistent.

[0041] In an additional embodiment, the ball socket can be clamped onto the spindle. Structurally, since this eliminates the need to hold the spindle in place, the reset spring can be positioned in parallel.

[0042] In some embodiments, the rear piston is configured to improve accuracy during spindle guidance. Additionally, this can help minimize friction between moving components during device operation and reduce the operating force required for the device. In some embodiments, the rear piston may include a front shoulder or, alternatively, an extended rear end to improve the connection between the rear end of the housing and the guide post of the housing.

[0043] The device may further include an alignment mechanism. In such cases, alignment is influenced by an alignment sleeve having a ramp with a surface profile. The spindle may be centered or have a central section enlarged. During priming of the device, the central section of the spindle contacts the alignment sleeve ramp, which brings the spindle to the central axis, thereby axially aligning the spindle and allowing the release of the spindle tip through a guide hole that receives the force of an operating spring.

[0044] In a preferred embodiment, a cassette used with the device accommodates a drug package, such as a solid formulation containing or containing therapeutic and / or prophylactic agents. This may include, in particular, a solid-dose vaccine for the prevention or treatment of a disease, or, for example, a solid-dose immunomodulator for the treatment or prevention of an allergic condition.

[0045] Due to the way the cassette is mounted at the front end of the delivery device (via the previously described bayonet arrangement), manual operation may be required for removal after operation. Users have pointed out that due to the geometry of the used cassette, it is difficult to remove it with controlled / precise timing without directly manually manipulating the cassette itself.

[0046] Therefore, the applicant has developed an additional technical solution that allows the cassette to be removed without physically handling the cassette itself.

[0047] The device described above may further include a cassette release and automatic ejection mechanism, wherein the front end and the rear end are axially rotatable relative to each other, and the front end is externally axially rotatable relative to the rear end, and the force of a reset spring acting on the front piston releases the cassette from internal structural constraints within the front end so as to cause automatic ejection of the cassette from the device.

[0048] Therefore, the present invention is:

[0049] Extending to a needleless device for delivering a therapeutic agent and / or a prophylactic agent, comprising: a rear end including a force generator for pushing out a solid drug including a therapeutic agent and / or a prophylactic agent from the above device; a front end including a front piston slidably mounted inside and for receiving a cassette containing the drug; and a cassette release and automatic ejection mechanism.

[0050] The front end and the rear end are axially rotatable relative to each other, and the front end is externally axially rotatable relative to the rear end, thereby releasing internal structural constraints for holding the cassette within the front end so that the force acting on the front piston causes the device to automatically eject the cassette. Effects of the invention

[0051] The new device arrangement described above facilitates semi-automatic disassembly (manual twisting to release followed by automatic ejection) via a simple and easily identifiable user movement to perform rapid and controlled disposal of used cassettes from the device. This further reduces the risk of contamination in needleless delivery and enables the efficient reuse of the device (removal and reloading along with drug consumables), which can be particularly useful in field-based environments.

[0052] While this arrangement constitutes a unique concept in itself by providing a combination and arrangement of features used to solve the technical problem of contamination by handling, in a particularly preferred embodiment, the present invention may be used in conjunction with the aforementioned device. This combination may be combined with the device to provide additional advantages in the field of needle-free delivery.

[0053] This unique combination of two aspects of the present invention provides additional advantages in the field of needle-free delivery of drugs and vaccines.

[0054] The present invention also relates to a needle-free method for preventing or treating a disease, comprising using the aforementioned device to deliver a solid drug containing a therapeutic agent or a prophylactic agent to a patient in need thereof.

[0055] Various aspects of the present invention are now described merely as examples with reference to the following drawings. Brief explanation of the drawing

[0056] FIG. 1 is a cross-sectional view of a needleless device according to the present invention in which the device is in an inactive position and before loading a cassette assembly; FIG. 1a is a cassette assembly for loading into a needleless delivery device containing a therapeutic agent and / or a prophylactic agent; FIG. 2 is a cross-sectional view of the device of FIG. 1 in which a cassette package containing a therapeutic agent and / or a prophylactic agent is inserted into the front end, rotatably engaged with the front end, and securely connected to be ready for use; FIG. 3 is an arrangement of the device of FIG. 1 during a priming (pre-operation) phase; FIG. 4 is an arrangement of the device of FIG. 1 immediately before automatic operation; FIG. 5 is an arrangement of the device of FIG. 1 immediately after operation; FIG. 6 is the device of FIG. 1 during a reset operation; FIG. 7 is an optional structural arrangement providing means for holding the spindle tip of the device in an axially offset position; FIG. 8 is another alternative structural arrangement providing means for holding the spindle tip of the device in an axially offset position; and FIGS. 9a to 9e are a combination of perspective and cross-sectional views of another embodiment of the present invention in which a needleless device includes a novel hands-free cassette ejection mechanism. Specific details for implementing the invention

[0057] This aspect of the present invention may also be combined with the device invention according to any previously described embodiment in relation to any feature illustrated in FIG. 1 to 8, depending on the example.

[0058] FIG. 1 illustrates an example of a needleless delivery device of the present invention. A cross-sectional view illustrates a delivery device (1) in a pre-operational state before a cassette is loaded into it.

[0059] The device (1) is configured to deliver a therapeutic and / or prophylactic agent (117), such as a medicine or vaccine, in solid, semi-solid, or liquid form, or a formulation containing a therapeutic / prophylactic agent. Delivery is achieved by effectively pushing the formulation or formulation (117), which is initially contained within a cassette assembly (100), into the body of a person or animal without the device itself pre-perforating the body. The delivery formulation may be formulated as a tablet or micro-tablet, a splinter, or other solid of dimensions that fit into a cassette. Typically, "solid dosage formulations" will be referred to throughout the description.

[0060] An example of a cassette assembly “cassette” is shown in FIG. 1a. At this point, the cassette (100) may be pre-packaged for hygiene and is unpacked only when it is ready to be loaded into the device (1).

[0061] The cassette (100) comprises a cassette body (103), a centrally located cassette pin (105), and a carriage (107) that accommodates a solid dosage formulation (117). These components are initially secured in place within the cassette body. The carriage is secured releaseably within the cassette body and is held in place by a pre-release leg (not shown) before operation. The cassette body further comprises an opening cone (111) at the foremost end or proximal position of the body.

[0062] The carriage includes two jaws (109) located at the front end of the carriage (107). The solid dosage formulation (117) is held by compression acting on the outer surface. In particular, the lateral compressive force of the jaws generates sufficient friction to hold the solid dosage (117) in this position within the carriage (107) during storage and general movement or transport of the cassette until the loading and operation point of the delivery device. The cassette pin (105) is located behind the solid dosage formulation (117) and adjacent to its rearward-facing end. The cassette pin is initially held in place within the carriage (107) by a set of pin release clips (115). The pin release clips are latched into the corresponding groove of the pin during assembly of the cassette (100).

[0063] The cassette (100) further includes a bayonet peg (112) that helps connect and disconnect the cassette from the actuator.

[0064] Referring again to FIG. 1, the needleless delivery device (1) itself comprises a housing (212) having a front end component / section (212a) and a rear end component / section (212b). The sections communicate internally so as to be operable with each other, and in the embodiment, two parts of the outer housing are arranged to rotate relative to each other.

[0065] The rear end component (212b) accommodates a force generating means, illustrated here as a compression or actuation spring (214) and a rear piston (215). The generated force is about 10-40 N, more preferably 15-35 N, most preferably 18-31 N. Behind the spring is a compression bar (234) that provides a contact surface on which the spring can act.

[0066] The front end component (212a) includes a front piston (218). The front piston (218) is slidably mounted within the device so that when the cassette is loaded, it pushes against the proximal end of the device, causing the front surface of the cassette to engage with the body surface and the cassette, and then the front piston slides upward within the front end component to prime the device and ultimately operate it. The front piston further defines a central axis (X) and a central hole (250) within it. A reset spring (244) is located at the front end and positioned between the front piston (218) and the alignment sleeve reset spring seat (209).

[0067] The front and rear end housing components (212a; 212b) are operationally connected through the spindle (210). The spindle (210) includes a spindle tip (211) configured to connect with the drive pin (105) of the cassette (when loaded) to ultimately push the therapeutic agent and / or prophylactic agent (117) out of the cassette (100). When the spindle is aligned with the central axis (X), the body of a person or animal is adjusted to pass through the central hole (250) during operation.

[0068] In this example, the proximal end, defined as the end closest to the side where the device's spindle comes into contact with the patient's skin, includes a spindle tip (211). This spindle tip is made of a material that can be attracted to and connected to a magnetic ring (205). Thus, the magnetic ring is configured to operate independently within the structural arrangement of the device as a spindle holding element and to stably hold the spindle tip in an axially offset position. The magnetic ring continues to operate until the device is operated. However, the feature of the magnetic ring (205) may be an equally alternative structure. It serves to laterally displace and hold the spindle and / or its tip. This feature, mentioned elsewhere, is clearly disclosed in combination with other features provided in the examples of the present invention, regardless of the specific form, provided that the independent function is satisfied (i.e., the structure is provided alone and arranged to perform that function and does not perform any other function). For example, a structural feature that already exists in the prior art and therefore has a primary function within the disclosure of the mechanism may suffer from the same problem as a reset failure and thus does not satisfy this essential requirement and thus will not solve the technical problem.

[0069] In the illustrated drawing, the rear piston (215) is adjacent to the spindle (210) by a rotational joint (225 / 221). The rear end of the spindle (210) is provided with a ball joint (221) connected to the rear piston through a socket (225). The ball socket connection serves to control the axial position of the spindle tip (211) as the spindle moves laterally between axial alignment and non-axial alignment with the hole of the front piston. Through this type of connection, the spindle can rotate with minimal friction, allowing the reset function to be deflected by the displacement mechanism, thereby improving accuracy and consistency.

[0070] The front and rear pistons communicate through the rear hole (243) and the spindle (210), and the end portion of the spindle (210) passes through the hole (243) which contacts the spring follower of the piston (215).

[0071] In this example, the spindle is additionally configured with an intermediate region (231) and a molded shoulder (231a) as illustrated. This feature is designed to connect along the profile of the alignment sleeve (260). This allows for automatic operation. The device must be able to operate automatically when the spindle is pulled from misalignment to axial alignment with the central hole (250) and fully primed.

[0072] Accordingly, the inner surface (260 / 232) of the alignment sleeve is generally formed to guide the spindle (shoulder area (231a) of the spindle middle section (231)) and force the spindle tip to move radially inward from the offset stop position. Ultimately, when the device is fully primed, the spindle tip is fully aligned with the central hole (250) of the front piston (218) and driven in a straight direction by the operating spring (214) to pass through the central hole (250) and come into contact with the drive pin (105).

[0073] Cassette connection:

[0074] Figure 2 shows how the cassette is aligned with the device and loaded into the device. It is also helpful for the connection between the cassette and the device to provide positive feedback to the user. Therefore, a bayonet-type connection that provides sufficient visual or other feedback indicating that the cassette is securely connected is desirable.

[0075] Accordingly, the present device further provides embodiments and examples in which a connection feedback mechanism provides tactile information that the cassette is firmly connected and ready to operate in addition to visual feedback.

[0076] In the current case, when ready to start the operation, the user aligns the cassette bayonet peg (112) of the cassette (100) with the bayonet opening (315) at the front end (212a) of the device (1) through the bayonet connecting ring (314) which includes the opening (315) and the dead stop. The user may be further assisted by connection indicators I and II (151, 251) provided on the cassette body and the proximal end of the front end, respectively. Some of these individual features, such as the peg (112) and connection indicators I / II (151, 251), can be more clearly visualized in FIG. 9a and FIG. 9e.

[0077] FIG. 2 illustrates a partially loaded cassette by pushing the cassette in the Y direction. The cassette can be aligned with the front end component without touching the cassette using an applicator or assembly aid. An assembly aid (not shown) may essentially be formed from the packaging in which the sterile cassette is stored before use, or it may be a separate component stored inside the package as part of the kit and added thereto. The assembly aid is formed to easily and temporarily surround the cassette or a part thereof for the alignment and insertion of the actuator and the cassette.

[0078] When the packaging is opened, the cassette may be additionally secured or a separate auxiliary device may already be mounted on the cassette, and it can be used to align with the actuator first without direct contact and insert the cassette into the delivery device.

[0079] When the cassette is inserted into the front end of the device in this direction, the reset spring (244) compresses the spindle (210) and the rear (278a) of the pre-release clip (278) to create contact. The cassette bayonet peg (112) contacts the bayonet connecting ring (314) dead stop.

[0080] When the cassette (100) is inserted into the actuator, contact is created between the cassette surface (116) and the front piston.

[0081] At the above point, the cassette (100), which is still held by the assembly aid, can be easily rotated clockwise to push the front piston into the device, for example, through a cam mechanism created by a cassette tactile lamp (not shown) and an internal lamp within the front piston. Then, when the cassette is locked in axial rotation, the front piston moves backward.

[0082] As the cassette (100) rotates until it reaches a rotation stop, the cassette tactile ramp leaves the front piston internal ramp due to a drop in the front piston internal ramp profile. This drop creates an internal shock as the front piston moves rapidly forward, generating a light vibration for tactile feedback. At this point, the cassette is firmly connected to the actuator.

[0083] Since the cassette peg (112) is now held in the track, the cassette (100) cannot move forward and the spindle (210) contacts the rear of the front piston pre-release clip (278a). The front piston (218) also helps to releaseably secure the spindle (210) in an axially misaligned position during priming by means of a physical surface connection between the spindle tip (211) and the rear of the front piston.

[0084] The pin release clip (115) of the cassette is contracted by the inner diameter size of the cassette body (103) and cannot be expanded. The pin release clip is 'V' shaped to control the axial position of the cassette pin (105) inside the carriage (107). Thus, the pin is made safer, and this movement control function prevents unintended forward motion of the carriage (107) from being transmitted to solid capacity before the user intentionally operates the device in the manner described below.

[0085] From the above point, the device is ready for use as shown in Fig. 3.

[0086] functioning:

[0087] In practice, the user holds the device against the housing and presses firmly against the patient's skin. This first applies tension to the skin, and then all pressure applied to the cassette compresses both the reset spring (244) and the actuation spring (214) through relative contact by the spindle (210). FIG. 4 shows the device with the compression against the skin initiated.

[0088] In this way, the spindle slides through the rear hole (243), and the rear end (221) of the spindle pushes the spring follower (215), compressing the operating spring (214) and charging potential energy into the device. The middle section (231) of the spindle contacts an alignment sleeve ramp that brings the spindle tip (211) toward the central axis (X), enabling the release of the spindle through the central hole (250) of the front piston. At the same time, the pre-release clip (278) of the front piston (218) is deflected when it contacts the front edge of the alignment sleeve, releasing the carriage (107) from the cassette body (103).

[0089] At the point shown in FIG. 4, the formed shoulder area (231a) is pulled toward the formed foremost surface (232), and the action of the reset spring (244) is reversed so that the operating spring (244) is fully charged and the axis alignment of the center hole (250) and the spindle tip is automatically operated.

[0090] By doing so, as illustrated in FIG. 5, the operating spring (244) applies force to the spindle tip (211) and the spindle (210) through the hole (250) to push the driving pin (105), thereby allowing the therapeutic agent and / or preventive agent (117) to be dispensed to a human or animal in turn.

[0091] Importantly, the longitudinal axis of the spindle cannot be aligned with the hole (250) until it reaches the required operating force set so that the formed shoulder area (231a) coincides with the point of movement in the general area of ​​the concave portion. Thus, a safety mechanism against accidental operation is provided.

[0092] The spindle advances the carriage (107), the drive pin (105), and the drug or solid dose (117) forward. The carriage locking jaw (109) stops upon striking the open cone (111) of the cassette body, and under the force of the drive pin (105), the solid dose or drug (117) continues to advance forward, releasing it from the carriage and cassette into the body of a person or animal without a separate needle or skin penetration. The spindle travels only a short distance before striking the drive pin. Therefore, the potential energy to penetrate the skin is important as the solid dose is required in the skin over a given distance. The drive pin, carriage, and solid dose move together until the carriage touches the open cone, at which point the approximate distance between the solid dose and the skin is 12 mm.

[0093] Reset

[0094] Since the device is reusable, it is desirable to detach the cassette, remove it from the actuator, and dispose of it in a safe manner so that the device can be used for new cassettes and drug delivery. Additional specific methods and features related to detaching the cassette are fully described below.

[0095] FIG. 6 shows the device immediately after the reset, with the spindle (210) in the stop position and the spring reset.

[0096] The reset operation requires the front piston (218) to move forward to a position where the spindle tip no longer engages with or is placed near the front piston center hole (250). As further described below, the reset spring (244) also pushes the front piston (218) and indirectly assists the used cassette so that it can be ejected from the device when the cassette is released, as described in detail below.

[0097] In the above example, the reset spring (244) does not pull the spindle (210) out of alignment with the hole (250); it does not provide a lateral force that causes the spindle to be displaced from the center. As mentioned, the spindle tip must be stably maintained out of the center axis.

[0098] In the above example, resetting is possible only by a spindle fixing element that supports the spindle to a transversely / radially offset position, particularly independently, after an operation such as a magnetic ring (205) pulling the spindle tip (211) backward as in FIG. 6. Thus, this feature acts as an active displacement means and is configured to maintain the spindle tip in an axially offset position until the priming and operating mechanism ignores the position bias.

[0099] The structural examples used herein are not limited, and any embodiment sufficient to provide axial reset by laterally displacing the spindle will be within the scope of the invention.

[0100] A unipolar radial magnetic ring located inside the rear open end of the front piston applies a magnetic field that attracts a metal spindle (10) hinged to a ball socket joint (225 / 221). During the reset phase, the front piston (212a) moves forward due to a reaction force applied by the reset spring (244), causing the spindle to be separated from the piston center hole (250) and pulled toward the magnetic ring (205).

[0101] The following additional examples illustrated in FIGS. 7 and 8 can be used as alternative solutions to the magnetic ring illustrated in the previous drawings to hold the spindle tip at the center axis of the hole (250). In each case, additional components or structural elements other than a standard spring (used as part of the reset) are present in the device. Thus, these features structurally and functionally satisfy the requirement to be configured exclusively to hold the spindle in an axially offset position.

[0102] One end of the reset spring (244) includes an additional function of an auxiliary spring wound in a spiral pattern as shown in FIG. 7. The inner part of the coil has an inner diameter slightly larger than the front end diameter of the spindle (211). The last coil formed spirally is off-center and applies a lateral force that keeps the spindle tip off-axis from the hole (250) when hinged to the ball socket joint (225 / 221). Using a ball and socket joint allows the spindle to rotate in all planes. Alternatively, in FIG. 8, the spring wire can be formed with a fixed geometry and attached to the front piston (20). The spring is formed as a double-pitch coil and rotates against the ball socket joint (225 / 221) and applies a lateral force that causes the tip of the spindle (211) to be off-axis and off-center from the hole (250).

[0103] Separating and ejecting the cassette from the device

[0104] A series of Figures 9a, 9b, 9c, 9d, and 9 illustrate a method by which a disposable cassette can be removed "hands-free" by a twist-release mechanism after solid volume injection. The arrangement is structurally defined within a housing section and utilizes some of the existing structures of both the cassette and the device to provide more functionality to the needleless device. This arrangement is not limited to this and may also be the type of needleless device described above.

[0105] In a particularly preferred embodiment including the example illustrated in FIGS. 9a to 9e, the features of a needleless device for hands-free cassette ejection are used in conjunction with the aforementioned example of a needleless device for the delivery of a therapeutic agent or a preventive agent.

[0106] The cassette used with the device here is intended to be a single-use item, and once the device operation is complete and the drug is delivered from it, the cassette is empty, so it must be removed from the device and disposed of.

[0107] As illustrated in FIG. 9a, to enable enhanced release and ejection of the cassette (100) from the device, the user may rotate or twist the front end casing (212a) by about 90 degrees relative to the rear end casing (212b) around the main axis (X). FIG. 9b shows the start of the "twist release" operation as the start of the operation in which the device is provided in cross-section.

[0108] At this time, release indicator I (351) provided at the end of the front end casing is moved in a rotational direction toward release indicator II (352) at the base of the rear end casing so that the two release indicators I and II are aligned and reach a dead stop. In this example, a visual guide (340) shown here in multiple chevron shapes can assist the user by clearly indicating the direction of movement that the front end must take to properly align the two release indicators.

[0109] The position after the front end housing casing is completely twisted is additionally shown in FIG. 9e, where release indicators I and II (351, 352) are aligned.

[0110] As movement occurs, the front end is internally connected by a twist release ring (357) that rotates axially through an interacting set of ribs. The twist release ring (357) includes a release finger (353) that can rotate axially on a dedicated track of the aforementioned bayonet connection ring (314). The track is also aligned with the axial position of the cassette bayonet peg (112) of the cassette (100). The release finger function (353) makes lateral contact with the cassette bayonet peg (112) when the cassette is connected.

[0111] The structural connection between these features means that when the front end casing (212a) is rotated as described, the twist release ring (357) rotates and engages with the cassette through contact with the cassette bayonet peg until the peg (112) reaches the bayonet opening (315) of the bayonet connecting ring (314). That is, the twisting mechanism of the outer casing allows the cassette to be released from an internal structure that was previously tightly constrained or fixed within the front end of the device. The features of the twist release ring (357) and the release finger (353) are more easily seen in the cross-sectional view of FIG. 9d without the cassette.

[0112] As described above, the cassette (100) comes into contact with the front piston (218). At this point, the reset spring (244) applies a counterforce to the front piston (218), so when the bayonet peg (112) reaches the opening (315) of the bayonet connecting ring (314), the front piston moves forward by the force of the spring. Any potential frictional force that could hold the cassette in the device is overcome by this force. As illustrated in FIGS. 9d and 9e, the rapid release of energy ensures that the cassette (100) is completely discharged from the front end (212a) and out of the device in the Y direction.

[0113] The ejection force is sufficient to allow the cassette to be disposed of directly into a suitable unit / container / tong, etc., without additional support. After removing the cassette, there is no need to handle it manually to transport it to the removal and / or disposal site.

[0114] After discharge, the user can stop the torsional force applied to the front end casing (212a) against the rear end casing (212b), which causes the front end to automatically return to its original position via an internal torsion spring (not shown). Then, the device is reset, a new cassette is inserted and connected to the device, and the device is prepared for reuse to deliver a new therapeutic or preventive agent by a needle-free operating mode.

Claims

Claim 1 A needleless device (1) for delivering at least one therapeutic agent and / or prophylactic agent, comprising a housing (212), wherein the housing comprises: a rear end (212b) comprising a force generator (214) and a rear piston (215); a front end (212a) for receiving a cassette (100) having a solid therapeutic agent and / or prophylactic agent (117) for delivery, wherein the housing comprises a front piston (218) having a center hole (250) and defining an axis, said front piston being slidably mounted within the front end; a spindle (210) positioned between the front end and the rear end, operably communicating the rear piston with the front end, having a spindle tip (211), and configured to be laterally movable between a position axially aligned with the center hole and an axially offset position; a reset spring seat (209); and a reset spring (244) positioned between the reset spring seat and the front piston. A needleless device characterized by including a spindle holding element structurally and functionally configured to exclusively hold the spindle in an axially offset position, wherein the spindle holding element holds the spindle tip in an axially offset position by means of attraction, or wherein the spindle holding element is configured to physically bias the spindle to an axially offset position. Claim 2 A needleless device according to claim 1, characterized in that the spindle retaining element is positioned proximal to and / or adjacent to the spindle tip. Claim 3 A needleless device according to claim 1 or 2, characterized in that the spindle retaining element is magnetic and optionally a magnetic ring. Claim 4 A needleless device according to claim 1 or 2, characterized in that the spindle comprises a material on which an attractive force acts by a spindle retaining element. Claim 5 A needleless device according to claim 1, wherein the spindle holding element is configured to physically bias the spindle to an axially offset position, the spindle holding element includes a coil housed within a reset spring, and the apex of the coil is axially offset. Claim 6 A needleless device according to claim 1, characterized in that the spindle retaining element includes a spring wire configured to fix the spindle in an axially offset position. Claim 7 A needleless device according to claim 1, further comprising a spindle alignment mechanism, wherein the spindle alignment mechanism optionally comprises an alignment sleeve having a ramp configured to guide an intermediate section of the spindle to induce the spindle tip to move to an axial alignment position. Claim 8 A needleless device according to claim 1, characterized in that the force generator includes an operating spring, and optionally, the reset spring and the operating spring are provided in parallel. Claim 9 A needleless device according to claim 1, characterized in that the rear piston is joined to the spindle by a rotary joint. Claim 10 A needleless device according to claim 9, wherein the rotary joint comprises a female connector or socket for receiving a corresponding male connector located at the rear end of the spindle. Claim 11 A needleless device according to claim 1, wherein the needleless device is formed in combination with a cassette for use with the needleless device, and the cassette is characterized by receiving a tablet, micro-tablet, or fragment containing one or more therapeutic agents and / or prophylactic agents. Claim 12 A needleless device according to claim 1, wherein the needleless device further comprises a connection feedback mechanism that provides a tactile signal to the user, in addition to visual feedback, that the cassette is firmly connected and the needleless device is ready to operate, and optionally the tactile signal is a vibration. Claim 13 A needleless device according to claim 1, further comprising a cassette release and automatic ejection mechanism, wherein the outer casing of the front end and the outer casing of the rear end are axially rotatable relative to each other, and when the casing is twisted, the cassette is released from internal structural constraints within the front end, and the cassette is automatically ejected from the device by the force of a reset spring acting on the front piston. Claim 14 delete Claim 15 delete Claim 16 delete Claim 17 delete Claim 18 delete Claim 19 delete

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